ULlg Pharma GMP Desc

LIBRARY GUIDE:
Pharmaceutical GMPs
Pharmaceutical GMPs Course Library
Table of Contents
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Courses Listed by Functional Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Course Descriptions:
A Step-by-Step Approach to Process Validation (PHDV79) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
A Tour of the FDA (PHDV60). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Application of GMPs to Analytical Laboratories (PHDV78) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Application of GMPs to Microbiology Laboratories (PHDV72) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Approach to Computerized Systems Validation and Compliance (ISPE02) . . . . . . . . . . . . . . . . . . . 9
Awareness of FDA Inspections for Pharmaceutical Manufacturers (PHA65) . . . . . . . . . . . . . . . . 9
Batch Record Reviews (PHA53) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Biotechnology: An Overview of Compliance Considerations (PHDV68) . . . . . . . . . . . . . . . . . . . . 10
Care and Handling of Drug Product Components, Labeling, Containers and
Closures (PHA41) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Change Control (PHA35) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
cGMPs for Combination Products (PHDV93) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Collecting Samples and Establishing Limits for Cleaning Validation (PHA54) . . . . . . . . . . . . . . . 11
Complaint Management for Pharmaceutical Manufacturers (PHA71) . . . . . . . . . . . . . . . . . . . . . 11
Conducting Annual Product Reviews (PHA45) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Corrective and Preventive Actions (PHA70). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
DEA Compliance (PHA40) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Documenting Validation Activities (PHA55) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Effectively Responding to FDA 483s and Warning Letters (PHDV70) . . . . . . . . . . . . . . . . . . . . . . . 13
Environmental Control and Monitoring (PHDV87). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Essentials of an Effective Calibration Program (PHDV75) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Failure Investigations for Pharmaceutical Manufacturers (PHA59-EU) . . . . . . . . . . . . . . . . . . . . . 15
FDA Training and Qualification Requirements (PHA67) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
GMPs for API Bulk Manufacturers (PHA52) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
GMP Principles for Batch Records (PHA60) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
GMP Principles of SOPs (PHA64) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
GMP Updates Enforcement Changes at the New FDA (PHDV91) . . . . . . . . . . . . . . . . . . . . . . . . . 16
Gowning for Sterile Manufacturing (PHA63) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
GMP Updates: Supply Chain Quality and Emerging Compliance (PHDV92) . . . . . . . . . . . . . . . . 17
GxPs (PHDV61) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Handling a Product Recall (PHDV64) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Handling an FDA Inspection (PHDV74) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
High Purity Water Systems (PHDV82) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
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How to Meet Drug Retention and Stability Testing Requirements (PHA43) . . . . . . . . . . . . . . . . 18

ICH Q7A: Introduction and Quality Management (ISPE05) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
ICH Q7A: Resources and Materials Management (ISPE06) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Implementing an Equipment Qualification Program (PHDV88) . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Interviewing Techniques (FDA27) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Introduction to GMPs (PHA38) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Key Concepts of Process Validation (PHDV77) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Maintenance and Cleaning of Drug Manufacturing Equipment (PHA44) . . . . . . . . . . . . . . . . . . 21
Managing FDA Inspections for Pharmaceutical Manufacturers (PHA66) . . . . . . . . . . . . . . . . . . . 21
Meeting GMP Training Requirements (PHDV76). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Meeting Process Requirements for Returned and Salvaged Drug Products (PHA42) . . . . . . . . 22
Orientation to GMP Compliance (PHDV73) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Packaging and Labeling of Finished Pharmaceuticals (PHA39) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Part 11: Electronic Records; Electronic Signatures (FDA31) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Part 11: Electronic Records and Signatures Changes in Enforcement Policy (FDA57) . . . . . . 24
Pharmaceutical Risk Management: Picking the Right CAPA Tools (PHA73) . . . . . . . . . . . . . . . . . 24
Pre- and Post-Approval FDA Drug Inspections (PHA75) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Principles of Aseptic Processing (PHDV71) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Principles of Auditing (PHDV69) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Principles of Cleaning Validation (PHA37) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Principles of FDA Inspections for Pharmaceutical Manufacturers (PHA61) . . . . . . . . . . . . . . . . . 26
Principles of Good Documentation (PHA74) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Requirements for Computerized Systems Validation and Compliance (ISPE01) . . . . . . . . . . . . 27
Resolving Out-of-Specification Test Results (PHA50) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Review of Basic Statistical Techniques (DEV44) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Risk Management in Pharmaceutical Manufacturing (PHA72) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Testing for Bacterial Endotoxins (PHDV86) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
The Design and Development of Software Used in Automated Process
Controls (PHDV80). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Understanding GMPs for Facilities and Equipment (PHDV63). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Understanding Post-Approval Changes (PHA49) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Understanding the Principles and Practices of Process Controls (PHA47). . . . . . . . . . . . . . . . . . . 30
Vendor Certification for Pharmaceutical Manufacturers (PHDV85) . . . . . . . . . . . . . . . . . . . . . . . . 30
Writing and Reviewing SOPs (PHA48) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Writing Validation Protocols (PHA51) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Courses Listed by Functional Area:

Core Knowledge QC Labs
Awareness of FDA Inspections for Pharmaceutical Application of GMPs to Analytical Laboratories . . . . . . . . . . . . PHDV78
Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA65 Application of GMPs to Microbial Laboratories . . . . . . . . . . . . PHDV72
Biotechnology: An Overview of Compliance Collecting Samples and Establishing Limits for
Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV68 Cleaning Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA54
Change Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA35 Documenting Validation Activities . . . . . . . . . . . . . . . . . . . . . . . . . . PHA55
GMPs for API Bulk Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . PHA52 Environmental Control and Monitoring . . . . . . . . . . . . . . . . . . . PHDV87
GMP Principles of SOPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA64 Failure Investigations for Pharmaceutical Manufacturers . . . PHA59
GxPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV61 Gowning for Sterile Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . PHA63
Introduction to GMPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA38 How to Meet Drug Retention and Stability
Key Concepts of Process Validation . . . . . . . . . . . . . . . . . . . . . . . . PHDV77 Testing Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA43
Orientation to GMP Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV73 Principles of Aseptic Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV71
Part 11 Electronic Records; Electronic Signatures . . . . . . . . . . . FDA31 Resolving Out-of-Specification Test Results . . . . . . . . . . . . . . . . . PHA50
Principles of Good Documentation . . . . . . . . . . . . . . . . . . . . . . . . PHDV65 Testing for Bacterial Endotoxins . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV86
Understanding Post-Approval Changes . . . . . . . . . . . . . . . . . . . . . PHA49
IT Validation
Production A Step-by-Step Approach to Process Validation . . . . . . . . . . . . PHDV79
Care and Handling of Drug Product Components, Labeling, Approach to Computerized Systems Validation
Containers and Closures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA41 and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ISPE02
DEA Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA40 Documenting Validation Activities . . . . . . . . . . . . . . . . . . . . . . . . . . PHA55
Environmental Control and Monitoring . . . . . . . . . . . . . . . . . . . PHDV87 Implementing an Equipment Qualification Program . . . . . . . PHDV88
GMP Principles for Batch Records . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA60 Part 11: Electronic Records and Signatures Changes in
Gowning for Sterile Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . PHA63 Enforcement Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FDA57
Maintenance and Cleaning of Drug Manufacturing Principles of Cleaning Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA37
Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA44 Requirements for Computerized Systems Validation
Packaging and Labeling of Finished Pharmaceuticals . . . . . . . PHA39 and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ISPE01
Principles of Aseptic Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV71 The Design and Development of Software Used
in Automated Process Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV80
Understanding GMPs for Facilities and Equipment . . . . . . . . PHDV63
Understanding the Principles and Practices of
Understanding the Principles of Process Controls . . . . . . . . . . . . PHA47 Process Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA47
Vendor Certification for Pharmaceutical Manufacturers . . . PHDV85 Writing Validation Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA51
Maintenance and Facilities Management/Supervision

DEA Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA40 A Tour of the FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV60
Environmental Control and Monitoring . . . . . . . . . . . . . . . . . . . PHDV87 Batch Record Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA53
Essentials of an Effective Calibration Program . . . . . . . . . . . . . PHDV75 Managing FDA Inspections for Pharmaceutical
Gowning for Sterile Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . PHA63 Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA66
High Purity Water Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV82 Meeting GMP Training Requirements . . . . . . . . . . . . . . . . . . . . . PHDV76
Implementing an Equipment Qualification Program . . . . . . . PHDV88 Part 11: Electronic Records; Electronic Signatures
Maintenance and Cleaning of Manufacturing Equipment . . PHA44 Changes in Enforcement Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FDA57
Understanding GMPs for Facilities and Equipment . . . . . . . . PHDV63 Pre- and Post-Approval FDA Inspections . . . . . . . . . . . . . . . . . . . PHDV66
Principles of Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV69
Principles of FDA Inspections for Pharmaceutical
Warehousing & Distribution Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA61
Care and Handling of Drug Product Components, Labeling, Writing and Reviewing SOPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA48
Containers and Closures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA41
Meeting Process Requirements for Returned and
Salvaged Drug Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA42
R&D/Design Controls Inspections

Review of Basic Statistical Techniques . . . . . . . . . . . . . . . . . . . . . . . DEV44 Handling an FDA Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV74
Managing FDA Inspections for Pharmaceutical
Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA66
QA Manufacturing Process
Interviewing Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FDA27
Batch Record Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA53
Pre- and Post-Approval FDA Drug nspections . . . . . . . . . . . . . . . . PHA75
Care and Handling of Drug Product Components, Labeling,
Containers, and Closures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA41 Principles of FDA Inspections for Pharmaceutical
Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA61
Corrective and Preventive Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA70
Environmental Control and Monitoring . . . . . . . . . . . . . . . . . . . PHDV87
Essentials of an Effective Calibration Program . . . . . . . . . . . . . PHDV75 QA Compliance
Failure Investigations for Pharmaceutical Manufacturers . . . PHA59 A Tour of the FDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV60
Gowning for Sterile Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . PHA63 Batch Record Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA53
High Purity Water Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV82 Complaint Management for Pharmaceutical
ICH Q7A: Introduction and Quality Management . . . . . . . . . . . . ISPE05 Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA72
ICH Q7A: Resources and Materials Management . . . . . . . . . . . . ISPE06 DEA Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA40
Implementing an Equipment Qualification Program . . . . . . . PHDV88 Effectively Responding to FDA 483s and Warning Letters . . PHDV70
Maintenance and Cleaning of Drug Manufacturing GMP Updates Supply Chain Quality
Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA44 and Emerging Compliance Concerns. . . . . . . . . . . . . . . . . . . . . . . . PHDV92
Packaging and Labeling of Finished Pharmaceuticals . . . . . . . PHA39 Handling a Product Recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV64
Principles of Aseptic Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV71 Part 11: Electronic Records and Signatures
Principles of Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV69 Changes in Enforcement Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FDA57
Understanding GMPs for Facilities and Equipment . . . . . . . . PHDV63 Principles of Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV69
Understanding the Principles and Practices of Managing FDA Inspections for Pharmaceutical
Process Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA47 Manufacturers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA66
Vendor Certification for Pharmaceutical Manufacturers . . . PHDV85 Meeting GMP Training Requirements . . . . . . . . . . . . . . . . . . . . . PHDV76
Meeting Process Requirements for Returned and
Salvaged Drug Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA42
QA Validation Risk Management in Pharmaceutical Manufacturing . . . . . . . PHA72
A Step-by-Step Approach to Process Validation . . . . . . . . . . . . PHDV79 Pharmaceutical Risk Management: Picking the
Approach to Computerized Systems Validation Right CAPA Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA73
and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ISPE02 Vendor Certification for Pharmaceutical Manufacturers . . . PHDV85
Documenting Validation Activities . . . . . . . . . . . . . . . . . . . . . . . . . . PHA55 Writing and Reviewing SOPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA48
Implementing an Equipment Qualification Program . . . . . . . PHDV88
Part 11: Electronic Records and Signatures
Changes in Enforcement Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FDA57 QA Quality Systems
Principles of Cleaning Validation . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA37 Conducting Annual Product Reviews . . . . . . . . . . . . . . . . . . . . . . . PHA45
Requirements for Computerized Systems Validation FDA Training and Qualification Requirements . . . . . . . . . . . . . . . PHA67
and Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ISPE01 How to Meet Drug Retention and Stability
The Design and Development of Software Used in Testing Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA43
Automated Process Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHDV80 Meeting GMP Training Requirements . . . . . . . . . . . . . . . . . . . . . PHDV76
Understanding the Principles and Practices of Writing and Reviewing SOPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA48
Process Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA47
Writing Validation Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PHA51
Combination Products
cGMPs for Combination Products . . . . . . . . . . . . . . . . . . . . . . . . . PHDV93
Overview:
UL EduNeerings Good Manufacturing Practices (GMP) Library is designed for
professionals in the Biotechnology and Pharmaceutical industries, and is comprised of
courses that cover underlying concepts and specific, advanced global information for
professionals in regulatory affairs. The global curriculum includes courses describing
Food and Drug Administration (FDA) regulations, European Union (EU) directives, and
International Conference on Harmonisation (ICH) guidance; many feature course content
provided by the FDA.
Content is continually updated to reflect changes in these regulations. Using innovative

technology, all content is fully customizable to meet the specific needs of your
employees and organization.
FDA Partnership
ULs Cooperative Research and Development Agreement (CRADA) with the FDA has
enabled the FDA to meet its significant training and documentation challenge and
also resulted in course content provided or reviewed and used by the FDA itself and
available to FDA-regulated Life Science companies all delivered in a valid and 21 CFR
Part 11-compliant environment. The CRADA was recently renewed through 2019 and
expanded to include new technologies.
When the symbol appears within the course description, it indicates

that the content for the course was provided by the US Food and Drug Administration
as a result of a CRADA between the FDA and UL.
LEGEND:
symbol indicates that the content

for this course was provided by the US FDA as a
result of a CRADA between the FDA and UL.
Course is available in one or more foreign
languages. Download Language Options for a
Global Workforce for details.
Learners have the option to take this course via a
mobile device, such as an iPad.
Course Descriptions:
A Step-by-Step Approach to Process Validation (PHDV79)
Using a sample product to demonstrate the nuts and bolts of Prerequisite:
process validation, this program outlines the important tasks Key Concepts of Process Validation.
performed during each phase of the validation lifecycle. Youll A basic understanding of the principles of process validation is
learn what type of information should (and should not) be recommended
included in validation documents and why processes must be
Topics include:
monitored once they are validated.
Tasks commonly executed during the Installation
Qualification (IQ), Operational Qualification (OQ) and
Performance Qualification (PQ)
Process monitoring
Detection and response to variation in processes
Revalidation
Validation documentation
References:
Two Applicable sections of 21 CFR Parts 211 and 820
FDA Guidelines on General Principles of Process Validation
FDA Guide to Inspection Solid Oral Dosage Forms Pre-/Post-Approval Issues
FDA Guide to Inspection Validation of Cleaning Processes
Process Validation Guidance for Medical Device Manufacturers, Global Harmonization Task Force,
Document GHTF.SG3.N99-10, June 1999. SG3
A Tour of the FDA (PHDV60)

FDA-regulated industries must work closely with the FDA to Topics include:
comply with industry regulations and create safe and effective FDA background
products. But how well do your employees know the FDA? The organizational structure of the FDA
A Tour of the FDA serves as an excellent introduction to its
Office of the Commissioner
organizational structure and gives an overview of the different
Office of Regional Affairs
enforcement actions available to this critical Agency. Take a
virtual tour of the FDA and learn about the function of each The six main program Centers
Center. Afterwards, explore different actions the Agency may take Enforcement actions:
Informal enforcement
in order to achieve compliance.
Formal enforcement
Application of GMPs to Analytical Laboratories (PHDV78)

A GMP has a significant effect on what we do in the lab. Even Topics include:
though GMP stands for Good Manufacturing Practice, these Lab Documents and Lab Practices
regulations also address how analytical labs should operate. A Raw Data
significant percentage of GMP regulations deal with laboratories,
Method Validation
sample handling, materials testing, documentation and control of
Calibration
laboratory procedures. These requirements are intended to assure
that manufactured products are safe, pure, effective and the Training
correct strength or potency. Out-of-Specification (OOS)
Computer Systems
After completing this course, you will be able to describe
GMP requirements as they apply to Analytical Laboratories,
recognise key concepts related to laboratory documents, learn
the requirements for laboratory training and gain a basic
understanding of laboratory calibration requirements.
Application of GMPs to Microbiology Laboratories (PHDV72)

This program addresses the application of GMP principles to Topics include:
microbiology laboratories and discusses the general principles of GMP requirements for microbiology laboratories
GMPs and their importance in microbiology laboratories. Aspects Laboratory documents and document control
of laboratory operations specifically required by GMPs and
Handling and documentation of raw data
considered industry practice will be reviewed, including: general
Controlling growth media
GMP requirements for microbiology laboratories, documents and
document control, handling of raw data and laboratory control. Aseptic techniques
Coverage of general laboratory control issues will be the focus Monitoring
of the program and cover GMP requirements for topics, such as: Laboratory equipment
handling of chemicals, documentation practices, sample handling, Training practices
prevention of cross-contamination, positive and negative controls, Out-of-Specification results
identification tests, sterility tests, handling of media, laboratory Regulatory References:
21 CFR 211.160; 21 CFR 211.165; 21 CFR 211.194
equipment, autoclaves and environmental monitoring. This is an FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories
excellent overview of specific laboratory requirements.
Approach to Computerized Systems Validation and Compliance (ISPE02)

This course, the second in a three-part series, describes an Topics include:
approach to the validation and compliance of computerized Description of a suitable framework for successful validation
systems used in the manufacture of pharmaceuticals, biologicals and compliance
and medical devices that are required to meet FDA regulations. Planning and reporting requirements for computerized systems
It outlines the kind of organization, policies and procedures, and validation
plans the FDA expects a manufacturing company to establish. Selecting a validation strategy
This course draws on current industry good practice. Though it Ongoing activities that the user firm should perform to ensure
also draws on FDA medical device guidance, this course is not continuing compliance
intended to describe an approach to developing software that
This course addresses the following:
subsequently becomes part of a medical device. General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA CDRH
and CBER, January 2002
Guidance for Industry Part 11; Electronic Records; Electronic Signatures Scope and Application,
Final Rule, August 2003
GAMP 5: GAMP Guide for Validation of Automated Systems (A Risk-Based Approach to Compliant
GxP Computerized Systems), March 2008
Guideline on General Principles of Process Validation, FDA, May 1987
Guide to Inspection of Computerized Systems in Drug Processing, FDA ORA, February 1983
Software Development Activities, FDA ORA, July 1987
Glossary of Computerized System and Software Development Terminology, FDA ORA, August 1995
Awareness of FDA Inspections for Pharmaceutical Manufacturers (PHA65)

In this course, you will be provided with a general awareness of Topics include:
FDA inspections of pharmaceutical testing and manufacturing Scope of FDA inspections
facilities, including purpose, types and areas/operations typically Procedures for companies to be prepared
inspected. You will also explore how firms should handle FDA
Guidance on how to interact with the FDA
inspections and interact effectively with FDA investigators.
What you can expect at the conclusion of an inspection
References:
Food, Drug and Cosmetic (FD&C) Act
Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections
Program 7356.002
Batch Record Reviews (PHA53)

This course defines batch records and describes how to properly Topics include:
perform a batch record review. The course also covers the Definition of a batch record review
current Good Manufacturing Practices (cGMP) requirements for General documentation requirements for cGMP-compliant
batch records and addresses how to maintain cGMP compliance batch records
throughout the review process. Organizing a batch record review
You will be able to explain the key elements and reasons for Key elements of reviewing manufacturing records
organized batch records and list many of the key components of Components of packaging record reviews
batch records. You will identify the elements of compliance and Reviewing laboratory data
completeness for batch records. Finally, you will understand the Review issues
scientific and compliance reasoning behind product disposition Batch disposition
decisions for many common product and process deviations and References:
21 CFR Part 211 Sections 188, 192 and 194
documentation of these decisions.
Biotechnology: An Overview of Compliance Considerations (PHDV68)

This course provides an overview of the fundamental compliance Topics include:
issues impacting the Biotechnology industry. It examines What are biotechnology-derived products?
compliance requirements specific to the biotechnology processes Why is the FDA concerned with cell culture and fermentation?
such as: cell culture and fermentation; culture media and growth;
Why is the FDA concerned with antibody production?
antibody production; extraction, isolation and purification;
What are the manufacturing controls for BDPs?
cleaning procedures; and laboratory controls and testing.
What are the unique challenges of processing and filling BDP?
What controls exist for BDPs?
What are BDPs tested for?
Care and Handling of Drug Product Components, Labeling, Containers and Closures (PHA41)
This course introduces the practices that control the handling and Topics include:
testing of medicinal products starting and packaging materials Definitions of components, containers and closures
while meeting requirements set forth in the GMP regulations. Impact of components, containers and closures on drug
product safety, purity and effectiveness
The learner is introduced to these key concepts by observing
Receipt, storage, sampling and testing of components,
a tour of a modern medicinal product manufacturing facility.
containers and closures
Proper procedures for the receipt, sampling, storage, testing
Documentation and records
and record-keeping of medicinal product starting and packaging
materials are covered in detail in this course. The relationship of components, containers and closures to
stability and reserve sample programs
References:
21 CFR Parts 177, 210 and 211
FDA Guideline Submitting Documentation for Container Closure Systems Used in the Packaging
of Human and Veterinary Drugs
Change Control (PHA35)

In this program, the concept of change control is presented in Topics include:
a way that places the learner in the role of a change control The regulatory requirements for change control
manager. Throughout the program, learners state the key Steps in the basic model of change control
elements of a change control program, identify key indicators of
Indicators of an improper change
change and learn the regulatory requirements for change control.
Elements of change control
The program also defines how to identify the groups involved
in change control and ways to describe the impact of change on FDA notification
product, process and people. References:
CFR 21 Parts:
210, 211: How changes are handled by drug GMPs
314: Changes to drug applications
601: Changes to biologic licenses
606: How changes are handled by biologic GMPs
814: Changes to device applications
820: How changes are handled by medical device GMPs
cGMPs for Combination Products (PHDV93)

After completing this course, you will be able to recognize the four Topics include:
different types of combination products. You will understand the Background
scope of the new regulation in 21 CFR Part 4, and how to comply Final Rule
with each of the drug, device, and biological product provisions.
Meeting compliance
You will understand the role of the Office of Combination
The Office of Combination Products
Products (OCP), how post-marketing modifications are made, and
how to report post-marketing adverse events. Post-approval modifications
Collecting Samples and Establishing Limits for Cleaning Validation (PHA54)

GMP regulations require that the equipment used in the Topics include:
manufacturing of a drug, medical device, or biologic product Sampling locations
be cleaned in such a way as to ensure that the quality, purity FDA-preferred sampling methods
and safety of a product will not be adversely affected. It is
Advantages and disadvantages of sampling methods
also important for manufacturers to set responsible limits for
Approaches used to set cleanliness limits
cleaning validation. After completing this course, you will be
able to identify the advantages and disadvantages of common Factors that influence cleanliness limits
sampling methods. You will also be able to recognize the need for Establishing cleanliness limits
References:
established limits of cleanliness in cleaning validation, as well as 21 CFR Parts 211.67 and 211.110
FDA Guide to Inspection Validation of Cleaning Processes Complaint Management for
be able to utilize formulas to derive safe, practical cleaning limits. Pharmaceutical Manufacturers
Complaint Management for Pharmaceutical Manufacturers (PHA71)

This course enables you to identify the primary elements in an Topics include:
effective pharmaceutical complaint handling system. You will System Elements
recognize how to document complaint information as required ADE
by FDA regulations and understand the basic requirements
Complaint File
for complaint evaluation and investigation. You will be able to
Complaint Analysis
recognize the types of complaints that must be reported to the FDA
according to the Adverse Drug Experiences (ADE) regulations, and Investigation
identify the importance of using statistical techniques to identify References:
21 CFR 211 Subpart J, 211.198, and 211.192
complaint trends that may indicate potential quality problems. 21 CFR 211 Part 310, Subpart D, Sec. 310.305
Conducting Annual Product Reviews (PHA45)

This course identifies the regulatory requirements and contents Topics include:
of an Annual Product Review (APR) as well as the possible benefits Annual Product Review (APR)
that APRs can yield. After completing this course you will know Benefits of APRs
the regulatory requirements and contents of an APR as well as the
Key components of the APR SOP
benefits of a good APR program.
References:
21 CFR Part 211 cGMP Subpart J, Records and Reports
21 CFR 211.180(e) General Requirements (for Annual Product Reviews)
21 CFR 211.192 Production Record Review
Corrective and Preventive Actions (PHA70)

The failure to take corrective and preventive actions can lead Topics include:
to continuing production problems, high scrap rates, product Quality System
failures, customer dissatisfaction, and, most seriously, harm to CAPA Program
a user or patient. When the FDA determines that a companys
Nonconformities
quality processes are not adequate or followed, they may take
Root Cause Analysis
enforcement actions to prevent the distribution of the products
produced by these processes. Change Control
After completing this course, you will be familiar with applicable

regulatory requirements and other important aspects of
implementing an effective Corrective and Preventive Actions
(CAPA) procedure. This course was prepared in accordance with
the FDAs Quality System guidance and experts from the Medical
Device industry. Implementing a CAPA system is a requirement
for both the Pharmaceutical and Medical Device industry.
DEA Compliance (PHA40)

This course provides an overview of the regulations found in Topics include:
21 CFR Chapter 2 governing the manufacture and distribution The DEAs role and the laws under the CSA
of drugs classified as controlled substances by the Controlled The DEAs classification of controlled substances
Substances Act (CSA) and as enforced by the Drug Enforcement
DEA requirements for the manufacture and distribution of a
Agency (DEA). controlled substance
Production and distribution controls
Controls for facilities that manufacture controlled substances
Employee controls
Recordkeeping requirements for manufacturers of controlled
substances
References:
21 CFR Chapter 1 Parts 210 and 211
21 CFR Chapter 2 Parts 1300-1399
Food, Drug and Cosmetic Act (FD&C Act)
Controlled Substance Act (CSA)
Documenting Validation Activities (PHA55)

The process of validation in the FDA-regulated industry is Topics include:
important to gain FDA acceptance. Every step of a particular Items that must be validated as specified by GMP requirements
process must be documented with written procedures and Validation documents requirements
validated with evidence. The key to successful validation is the
Equipment validation
understanding that validation must be documented. The FDA
Proper documentation of materials
issues Warning Letters to manufacturers that have inadequate
validation activities. These observations are considered to be Process documentation
violations of GMP regulations and not violations of validation. Documentation of procedures involving personnel
References:
This course provides the learner with an overview of the types of 21 CFR Parts 210 and 211 and 820 Quality System Regulation
Guideline on General Principles of Process Validation, Sec VIIIA3
documentation that are at the core of sound validation programs. Guide to Inspections of Oral Solid Dosage Forms Pre-/Post-Approval Issues for Development
The learner is introduced to the primary documents of validation, and Validation
Guideline for Submitting Supporting Documentation on Drug Applications for the
as well as the documentation requirements for equipment, Manufacture of Drug Products
materials, processes and products, and personnel.
Effectively Responding to FDA 483s and Warning Letters (PHDV70)

No company wants to receive an FDA 483 or Warning Letter for Topics include:
adverse findings after an FDA inspection, but it does happen. FDA 483s
If an FDA inspection yields any Good Manufacturing Practices Responding to 483s
(GMP) compliance concerns or faults during the inspection, the
Purpose and scope of Warning Letters
FDA is required to fill out a report immediately. It is important
Responding to Warning Letters
to understand the purpose and scope of both FDA 483s and
Warning Letters so as to be able to respond to them quickly and Avoiding mistakes when responding
effectively. After completing this course, you will understand the Scale-Up and Post Approval Changes (SUPAC) guidance
basic principles of FDA 483s and their use, and the use of Warning This course covers material referenced or implied from 21 CFR, Parts 210 and 211; 21 CFR, Part 820
(medical devices); and section 704 of the FD&C Act.
Letters. You will also be able to describe the key aspects of written
responses to both FDA 483s and Warning Letters.
Environmental Control and Monitoring (PHDV87)

Many important components and controls are necessary to assure Topics include:
high-quality pharmaceutical or medical device products two of An introduction to environmental control and monitoring
the most important are environmental control and environmental Components of effective environmental control
monitoring. Environmental control and monitoring go hand-in-
Facility and equipment design that assure environmental
hand. Together, they help to create and maintain a manufacturing control
environment that will prevent product contamination. This course
Personnel practices that ensure effective environmental
examines the establishment of environmental control elements control
in the design of GMP operations and the monitoring necessary
Cleaning methods to ensure effective environmental control
to assure proper function. It will review the importance of
Necessary contents of the environmental monitoring SOP
maintaining an acceptable manufacturing environment, including References:
control parameters and related regulatory requirements. FDA Guideline on Sterile Drug Products Produced by Aseptic Processing, June 1987
Fundamentals of a Microbiological Environmental Monitoring Program, FDA Environmental
Task Force, Technical Report, Nov. 13, 1990
21 CFR Part 211.160
Essentials of an Effective Calibration Program (PHDV75)

Injuries, fatalities or major class action suits filed against the Topics include:
manufacturer can result when products are produced with Calibration
out-of-calibration equipment. When lives are at stake and a Calibration standards
companys reputation is in the balance, equipment must always
GMP requirements for the calibration program
be operating to its precise specifications. This course is designed
Essential elements for a calibration program
to help the learner identify key concepts of calibration and
References:
recognize the importance of calibration reference standards and 21 CFR 211.67, 21 CFR 211.68 and 21 CFR 211.160(b)(4), 21 CFR 820.72
ANSI/NCSL Z540-I-1994 Calibration Laboratories and Measuring and Test Equipment
GMP calibration requirements in order to ensure an effective General Requirements
ISO 10012-1:1992(E), Quality Assurance Requirements for Measuring Equipment
calibration program. Part 1: Metrological Conrmation System for Measuring Equipment
ISO/IEC Guide 25, 1990, General Requirements for the Competence of Calibration and
Testing Laboratories
Failure Investigations for Pharmaceutical Manufacturers (PHA59-EU)

This course explains the GMP regulations related to failure Topics include:
investigations and the key components of a good investigation. What events lead to a failure investigation?
After completing this course, the learner will be able to identify
What is a root cause?
how to determine the root cause of a failure and recognize
What is a corrective action?
the importance of corrective actions and follow-ups to failure
Why is follow-up important in failure investigations?
investigations.
What is the purpose of an investigation report?
FDA Training and Qualification Requirements (PHA67)

Effective personnel training and qualification can produce a Topics include:
competent workforce, which can lead to a reduction of errors/ Personnel training and qualification
deviations, customer complaints, regulatory risk and operational Who is responsible for personnel training and qualification
costs. This course will address the measures required to stay in
Requirements for the training and qualification system
compliance with FDA regulations and the requirements needed to
Specific requirements for training
implement an effective training and qualification program.
Specific requirements for personnel qualification
This course will identify FDA requirements concerning training Metrics used to measure training and qualifications
and qualification, responsibilities of personnel, records that need References:
21 CFR 211.25(a) cGMP for Finished Pharmaceuticals
to be maintained, and how to measure training and qualification. 21 CFR 58.29(a)(b) Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR 820.25(a)(b) Quality System Regulation
GMPs for API Bulk Manufacturers (PHA52)

The Food, Drug, and Cosmetic Act (FD&C) requires Active Topics include:
Pharmaceutical Ingredients (APIs) to be manufactured in cGMP requirements for API manufacturing personnel
accordance with cGMPs. There are, however, no specific
GMP requirements for building and facilities
regulations in 21 CFR for APIs like there are for drug products.
cGMP requirements for manufacturing equipment
The FDA is proposing regulations, however, they are not yet final.
Requirements for materials and packaging components
This course is about the basic concepts of GMPs and how they
can be applied to the manufacture of APIs. Process controls for APIs
Laboratory controls for APIs
Recordkeeping requirements
References:
Food, Drug and Cosmetic Act (FD&C Act)
21 CFR Chapter 1 Parts 210, 211, 606 and 820
GMP Principles for Batch Records (PHA60)

Pharmaceutical batch records are essential to ensuring that Topics include:
regulatory and product quality attributes are achieved. In this Batch records
course, you will explore the required components of batch records
FDA requirements for cGMP-compliant batch records
and the importance of carefully documenting the information
Manufacturing records
generated during the manufacturing, packaging, and in-process
Packaging batch records
testing of pharmaceutical products. This course is intended for
manufacturing and packaging operators who perform functions Deviations
directly related to producing a batch of material or product and Batch record review
who record critical data on batch records. References:
21 CFR 211.100, 211.101, 211.130, 211.180, 211.188, and 211.192
GMP Principles of SOPs (PHA64)

This course reviews the principles of SOPs for an FDA-regulated Topics include:
environment and provides employees with a working knowledge What are SOPs
of what SOPs are, their purpose, how they are structured,
What information is contained in a SOP
information provided and change control. After completing
Change control
this course, you will be able to recognize how to handle changes
Implementation of SOPs in the workplace
to SOPs, as well as how SOPs are used in the workplace.
References:
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 820 Quality System Regulation for Medical Devices
21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections program
7356.002
GMP Updates Enforcement Changes at the New FDA (PHDV91)

After completing this course, you will be familiar with the Topics include:
significant changes coming to the FDA in its stepped up emphasis Current Environment Supplier Monitoring
on inspections, warning letters, enforcement, and follow up. You Prevention
Enforcement Model
will learn about the challenges facing FDA and the industry with
Expectations Future
outsourcing manufacturing, and you will also learn about what
Supply Chain
companies can do to prepare for the coming changes.
Gowning for Sterile Manufacturing (PHA63)

In this course you will be able to identify important sources Prerequisites:
and types of contamination in a manufacturing environment, Principles of Aseptic Processing
recognize the importance of health issues and personal hygiene Principles of Sterilization
and describe the staged entry and use of cleanrooms. You will also
Topics include:
learn to identify important practices and procedures for proper
Why gowning is important
gowning.
Types of contamination
Preparation in gowning rooms
Gowning basics and procedures
References:
21 CFR 211.28 (a-d)
21 CFR 211.56
QSR 820.70
GMP Updates: Supply Chain Quality and Emerging Compliance (PHDV92)

This course focuses on the regulatory attention devoted to Topics include:
supply chain management, and references U.S. FDAs 2013 draft Challenges
guidance, Contract Manufacturing Arrangements for Drugs: FDA Response
Quality Agreements, in which the agency recommends that
Company Improvements
companies define, establish, and document the responsibilities of
each party (or all parties) involved in the contract manufacturing
of drugs
GxPs (PHDV61)
GxP is a collective term for the regulations known as Good Topics include:
Laboratory Practices (GLPs), Good Clinical Practices (GCPs) and GxPs
Good Manufacturing Practices (GMPs). Without these combined GLPs
regulations, the safety and efficacy of the pharmaceutical and
GCPs
medical device products would be in question. After completing
GMPs
this course, you will understand how these practices relate to
References:
each step in the development and manufacture of new drugs, This course references regulations that are found in the Code of Federal Regulations Title 21
biologics and medical devices..
Handling a Product Recall (PHDV64)

Companies undergo product recalls for various problems; it could Topics include:
happen to any company. A product recall is probably the most Product recalls
difficult and stressful situation that can be encountered in this
Steps in conducting a recall
Life Science industry. Because product recall can be critical, you
Roles and responsibilities during product recall
need to understand what it is and how to handle it.
Effect of a recall on a company
This course defines product recalls and explains their impact Who a company must communicate with during a recall
on the manufacturer, FDA requirements and enforcement when Note: This course addresses key aspects of 21 CFR, Part 7 Enforcement Policy and SMDA of 1990.
dealing with a product recall, and the basic steps for handling
a recall.
Handling an FDA Inspection (PHDV74)

This course reviews the basics of handling an FDA inspection of Topics include:
a Pharmaceutical and Medical Device manufacturing facility. Personnel Conduct Samples and Photos
The course will clarify the roles and responsibilities of personnel Enforcement
Inspection Types
during an inspection with an emphasis on being prepared and
The Process End of Inspection
maintaining a positive, professional relationship with the FDA.
Records
References:
Food, Drug, and Cosmetic (FD&C) Act
21 CFR Parts 10, 20, 207, 210, 211, 606, and 820
FDA Guide to Inspection Dosage Form Drug Manufacturers cGMPs
FDA Guide to Inspection Solid Oral Dosage Forms Pre/Post Approval Issues
High Purity Water Systems (PHDV82)

Water is one of the most important materials used in the Topics include:
manufacturing of pharmaceutical and medical device products. Defining high-purity water
Because water quality can directly impact product quality,
Types or qualities of water
GMP regulations require that water receives the same scrutiny,
Determining the quality of the required water
monitoring and control as any other critical raw material used
in manufacturing processes. As a result, FDA investigators
Steps for producing WFI water
commonly cite manufacturing firms for their failure to assure Monitoring high-purity water systems
the quality of the water in use. Monitoring approaches
Water system problems
After completing this course, you will be able to identify the
Correcting water system problems
typical uses of water in pharmaceutical and medical device
Regulatory References:
manufacturing. You will also be able to recognize the general FDA Guide to Inspections of High Purity Water Systems, July 1993
process for producing high-quality water, various approaches 21 CFR Parts 211 and 820
for monitoring a water system, and possible methods of solving

water system problems.
How to Meet Drug Retention and Stability Testing Requirements (PHA43)

This course is designed to provide the learner with an Topics include:
understanding of the principles and regulations of drug stability
Stability testing program
testing and requirements for maintaining reserve samples. After
completing this course, you will recognize the importance of Effects of environmental conditions on product stability
maintaining drug safety and effectiveness over a products shelf Determining shelf life
life. You will be familiar with basic Principles of Stability and the Requirements for stability testing protocols
relationship to product safety and effectiveness. Purpose of retention testing
This course addresses the following:

21 CFR Subpart I, Laboratory Controls Part 211.166 Stability Testing, and Part 211.170 Reserve
Samples
Guidance for Industry: ICH Q1A (R2) Stability Testing of New Drug Substances and Products,
November, 2003
ICH Q7A: Introduction and Quality Management (ISPE05)

This is the first in a series of courses designed to instruct on Prerequisites:
cGMPs for active pharmaceutical ingredients (APIs), as set out by The learner should have a working knowledge of current GMPs
the ICH Q7A Guideline. This course covers the Introduction to ICH for drug products as set out in the Code of Federal Regulations,
Q7A and Quality Management for API manufacture. CFR 21 Parts 210 and 211, as well as a basic understanding of
chemical and biological processes used in the manufacture of APIs.
After completing this course, you will be able to describe the
purpose of the Q7A Guideline and how it fits in with current Topics:
regulatory expectations and practices in the United States
What is Q7A
especially in the context of the FDAs systems-based inspections
How APIs differ from drug products
program, 7356.002F. You will also be able to recognize the basic
When Q7A guidelines apply to the API manufacturing process
terminology and applications of Q7A and the principles of an
effective quality management system for API manufacture. The purpose of quality management
Key production activity that ensures API quality
Why a formal change control system is needed
What complaints and recalls share in common
This course incorporates information from Guidance for Industry: Q7A GMP Guidance for APIs.
http://www.fda.gov/cber/gdlns/ichactive.pdf
Note: Content for this course is provided by the International Society of Pharmaceutical
Engineers (ISPE).
ICH Q7A: Resources and Materials Management (ISPE06)

This is the second in a series of courses designed to instruct Prerequisite:
on GMPs for Active Pharmaceutical Ingredients (APIs), as set ICH Q7A: Introduction and Quality Management
out by the International Conference on Harmonisation (ICH)
Topics include:
Q7A Guideline. This course covers qualifications for personnel,
Personnel qualifications
requirements for buildings used in API manufacturing,
Buildings and facilities requirements used for
considerations for API manufacturing equipment, and materials
management. Learners should have a working knowledge of API manufacturing
current GMPs for drug products as set out in CFR 21 Parts 210 and Process equipment requirements used for
211. Learners should also have a basic understanding of chemical API manufacturing
and biological processes used in the manufacture of APIs. After Purpose of materials management
completing this course, you will be able to recognize materials Storage/Distribution
management and warehousing and distribution procedures.
Guidance for Industry: Q7A GMP Guidance for API
www.fda.gov/cber/gdlns/ichactive.pdf
Note: Content for this course is provided by the International Society of Pharmaceutical
Engineers (ISPE).
Implementing an Equipment Qualification Program (PHDV88)

Equipment qualification serves as the foundation for several Topics include:
currently recognized Health Care industry compliance Importance of equipment qualification
requirements, such as analytical method, process, cleaning and
Equipment qualification protocol
automated systems validation. A well-developed and established
Design Qualification (DQ)
equipment qualification program allows a company to meet
Installation Qualification (IQ)
cGMP requirements and save on operational costs at the same
time. This course is designed to provide an introductory overview Operational Qualification (OQ)
of the equipment qualification requirements that apply to the Performance Qualification (PQ)
Pharmaceutical, Biotechnology and Medical Device industries. Legacy Equipment Qualification (LEQ)
After completing this course, you will be able to define equipment

qualification, identify the importance of equipment qualification,
recognize the GMP requirements in this area and identify the
steps that must be followed in order to successfully implement
equipment qualification.
Interviewing Techniques (FDA27)

Interviews are an important part of virtually every operation Topics include:
performed by FDA inspectors, investigators and analysts. Purpose of an interview
Interviews are conducted during inspections, sample collections, Preparing for an interview
recalls and special investigations; therefore, it is important that
Specific considerations for the persons being interviewed
FDA field personnel possess good interviewing skills and develop
Traits of a successful interviewer
them as they move forward in their careers.
Keys to asking effective questions
After completing this course you will be able to recognize the Nonverbal behaviors you should observe
fundamentals of conducting an effective interview. You will be References:
Food, Drug and Cosmetic (FD&C) Act
able to identify the traits of a successful interviewer and the Investigations Operations Manual (IOM)
DHRD Basic Investigative Interviewing Course
importance of appropriate interpersonal skills. You will also be
able to identify appropriate questioning techniques to use in an
interview.
Introduction to GMPs (PHA38)

This interactive program introduces Good Manufacturing Topics include:
Practices (GMP) and the current regulations that pharmaceutical What are GMPs?
manufacturers must follow. It highlights employee What GMP requirements apply to basic procedures?
responsibilities and the role of FDA and the Food, Drug &
What are the GMP requirements for documentation?
Cosmetic Act. Examples of GMPs are included.
What are your responsibilities?
How can you control contamination?
How does FDA enforce compliance issues?
Key Concepts of Process Validation (PHDV77)

Through the use of interactive examples focused on producing a Topics include:
fictitious product, this program will outline the actual activities Why processes are validated
that take place before, during and following the validation of a Process validation vs. verification
process. Throughout the program, you will learn terminology and
Types of processes that must be validated
concepts related to the validation of manufacturing processes,
Common approaches to validation
the regulatory requirements for process validation and validation
approaches. A validation lifecycle model is used to explain the The validation lifecycle
References:
major elements of validation and how they relate to one another. This course is based upon applicable sections of 21 CFR Parts 211 and 820, as well as:
FDA Guidelines on General Principles of Process Validation.
After completing this course, you will be familiar with applicable FDA Guide to Inspection Solid Oral Dosage Forms Pre-/Post-Approval Issues.
FDA Guide to Inspection Validation of Cleaning Processes.
regulatory requirements and other important aspects of process Process Validation Guidance for Medical Device Manufacturers, Global Harmonization Task Force,
validation. SG3. Document GHTF.SG3.N99-10, June 1999.
Note: This program serves as a prerequisite for A Step-By-Step Approach to Process Validation
Activities.
Maintenance and Cleaning of Drug Manufacturing Equipment (PHA44)

Properly designed, constructed, cleaned, and maintained equipment in their manufacturing. Additionally, learners will be
equipment lies at the core of the process control necessary to able to identify the necessary documentation and records for
consistently manufacture pure, high quality drug products. This equipment used in the manufacture of prescription and over-the-
course reflects FDAs Guidance Document, Process Validation: counter drugs.
General Principles and Practices and focuses on the life cycle
validation process thats made up of three stages: Process Design,
Topics include:
Process Qualification and Continued Process Verification, and how What are the GMPs for equipment design and construction?
these impact the maintenance and cleaning of equipment. What are the objectives of equipment maintenance and
cleaning?
The course places the learner in the role of the new manager of How is equipment qualified?
the Engineering Department, in which the learner is involved in What are the GMP requirements for identifying equipment?
equipment selection, installation, qualification, and maintenance.
What are the GMP requirements for equipment records?
After taking this course, you will be able to describe cleaning and
maintenance practices for equipment used in manufacturing,
as well as how a pharmaceutical company incorporates this
Managing FDA Inspections for Pharmaceutical Manufacturers (PHA66)

This course reviews effective measures for managing FDA Topics include:
inspections of Pharmaceutical drug manufacturing facilities. The How should companies prepare for FDA inspections?
measures reviewed include preparation, interaction, handling and How does an Inspection Guide help firms manage FDA
follow-up. inspections?
What systems are covered under the FDAs Systems-Based
Approach for Inspections?
How can you ensure the best interaction with the FDA?
How should FDA inspections be managed?
Why is managing the inspection closeout meeting important?
How should companies follow up to FDA inspections?
Meeting GMP Training Requirements (PHDV76)

In order to produce products that are pure, safe, effective and in Topics include:
compliance with FDA regulations, it is necessary to understand GMP training requirements
the nature of GMP Training Requirements. GMP regulations are Types of GMP training
very clear as to what training is required. This interactive program
Approaches to GMP training
introduces you to these training requirements and asks you to
Training verification
apply them to actual FDA-regulated industry situations.
References:
21 CFR Parts 211, 820 and 600
This course introduces the requirements and different types of
training specified in GMPs. Learners will also understand several
varied approaches to training and understand the advantages
and disadvantages of each. Finally, learners will understand the
more technical aspects of training, why each is important to
GMP compliance and identify examples of achieving training
compliance.
Meeting Process Requirements for Returned and Salvaged Drug Products (PHA42)
Learn the specific requirements set forth in the GMP Regulations Topics include:
to assure the purity, safety and effectiveness of returned and Returned and salvaged drug products
salvaged drugs when they are deemed suitable for distribution. Procedures for processing returned and salvaged products
This program examines the relationship of product complaints
Evaluating returns for resale
and investigations to drug products that have been returned or
Products that can be salvaged
salvaged and how these may impact what can be done with such
drug products. Documentation requirements for returned and salvaged
products
References:
This program addresses the unique principles and practices 21 CFR Part 211.204 Returned Drug Products
involved in the proper handling and processing of returned and 21 CFR Part 211.208 Drug Product Salvaging
salvaged products, GMP requirements, acceptable practices and

procedures, and documentation.
Orientation to GMP Compliance (PHDV73)

Many people, including those who work in the Drug and Medical Topics include:
Device industries, find regulations confusing. Because FDA What regulations are
regulations have a direct impact on how you do your job, this The goal of GMP regulations
interactive program is designed to take the mystery out of these
Interpreting the regulations
regulations by giving you insight on how they are applied and
Enforcing regulations
interpreted. You will better understand how the FDA and your
References:
own companys compliance professionals interpret and apply Food, Drug and Cosmetic Act
CFR 21 Chapter 1
these important regulations. CFR 21 Parts 210 and 211
CFR 21 Part 11
FDA Good Guidance Practices
This course explains how the Food, Drug and Cosmetic (FD&C) Act FDA Guide to Inspection Dosage Form Drug Manufacturers cGMPs
are tied to the Code of Federal Regulations Title 21 and how the
GMPs are key elements in those regulations. In addition, learners
will understand how various FDA publications aid in interpreting
and determining its expectations.
Packaging and Labeling of Finished Pharmaceuticals (PHA39)

This course examines the packaging and labeling of pharmaceutical Topics include:
products. Included is a discussion on the importance of these GMP principles for packaging and labeling
activities, possible impact of mix-ups that can occur with packaging Primary and secondary packaging
or labeling and the controls for these activities required by the
Consumer protection
cGMP regulations. In addition, typical approaches taken with
Preventing packaging mix-ups
packaging to protect consumers are reviewed.
Proper product labeling
Label control prior to production
Online controls used during production
Reference:
The content of this course is based on 21 CFR Parts 211.122 to 211.137 and 211.188; the FDA Guide to
Inspection of Dosage Form Drug Manufacturers cGMPs; and 21 CFR Parts 201, 606 and 610
Part 11: Electronic Records; Electronic Signatures (FDA31)

The principle purpose of 21 CFR Part 11 is to ensure that when
electronic records and signatures are used, they meet the minimum
requirements of trustworthiness, reliability and compatibility
with the FDAs mission of public health and safety. This course
introduces regulatory requirements for electronic records and
electronic signatures, as well as FDA expectations for compliance.
You will learn specific Part 11 requirements that govern the use of
electronic records and signatures as well as FDA enforcement of
Part 11.
Part 11: Electronic Records and Signatures Changes in Enforcement Policy (FDA57)
This course will provide the learner with an understanding of Topics include:
the change in enforcement policy of the FDA for 21 CFR Part 11, Part 11
Electronic Records; Electronic Signatures. The course discusses Basic requirements for electronic records
the Guidance for Industry; Part 11, Electronic Records; Electronic
Security requirements for electronic records
Signatures Scope and Application, August 2003.
Basic requirements for electronic signatures
Controls for electronic signatures
FDA enforcement of Part 11
References:
21 CFR Part 11 Electronic Records; Electronic Signatures
FDA Guidance for Industry; Part 11, Electronic Records; Electronic Signatures Scope and
Application, August 2003
Note: This course was created by UL in collaboration with EduQuest, Inc.
Pharmaceutical Risk Management: Picking the Right CAPA Tools (PHA73) EU

One of the elements in FDAs Q10 Pharmaceutical Quality System Topics include:
document is corrective and preventive action (CAPA). This course CAPA Programs
focuses on the CAPA process, including the investigation process, Data Monitoring and Review
root cause determination, data collection, and preventive actions
Analysis
that come from that analysis, based on industry best practices.
CAPA Software Tools
Learners will also become familiar with software tools available
that can help achieve an effective CAPA process.
Pre- and Post-Approval FDA Drug Inspections (PHA75)

This course explores pre- and post-approval FDA drug inspections. Topics include:
The purpose and focus of each type of inspection is discussed,
Pre-approval inspections
along with the key inspectional targets of each. For pre-approval
inspections, the course focuses on the process and documentation Focus of Pre- and Post-Approval Inspections (PAI)
related to demonstrating equivalence of the bio-clinical batches to Post-approval inspections
the proposed commercial product. Topics also include: evaluation Reasons for post-approval inspections
of bio-clinical batches, raw materials, manufacturing process, Possible FDA inspection outcomes
finished product, and general GMP compliance. For post-approval
inspections, the discussion will primarily focus on general GMP
compliance issues. The various inspection outcomes for each type
of inspection will also be covered.
Principles of Aseptic Processing (PHDV71)

Because microbiological and particulate contamination can Topics include:
potentially cause serious health problems in animals and humans, Aseptic processing
it is vital that sterile products be manufactured, filled and Controlling the aseptic processing environment
packaged in an aseptic environment. This course will address
Employee requirements for aseptic processing
the general principles and practices necessary to assure product
Preparing components for sterile products
sterility and safety related to aseptic processing. It will also
address the GMP principles for aseptic processing as required by Media fill
both the European Union (EU) and the FDA. Environmental monitoring programs
Principles of Auditing (PHDV69)

This program focuses on the purpose and conduct of internal and Topics include:
external quality audits. It discusses the purpose of conducting Audits
audits and focuses on the benefits to be derived if audits are Types of audits
conducted properly. It begins with a discussion on establishing
Benefits of performing an audit
an audit program to achieve internal GMP compliance. The
Preparing for an audit
course focuses on the actual preparation, conduct and follow-up
associated with an internal audit. The course also stresses the Performing an audit
importance of establishing corrective action and follow-up, and Audit closeout
References:
how these aspects of the audit program can yield opportunities 21 CFR Parts 211.84 and 820.22
FDA Compliance Program 7346.832 Pre-Approval Inspections
and quality improvements will be illustrated. QSIT Guidance
Principles of Cleaning Validation (PHA37)

The cleaning of equipment used in a pharmaceutical operation Topics include:
can be a complex process. Even the smallest amount of chemical Cleaning validation
residual material in equipment can be extremely dangerous Choosing the proper cleaning method
even deadly. It is for these reasons that the FDA enhanced
Why a cleaning SOP is necessary
cleaning requirements for Pharmaceutical manufacturers.
Assessing clean
In this course you will learn the basics of cleaning validation Testing for chemical residues
in pharmaceutical manufacturing operations. The course also Proving methods
focuses on cleaning procedures and the development of methods Acceptance limits
and approaches to validating your processes. In addition,
Testing and monitoring the cleaning procedures
assessing clean and developing methodologies for sampling and
Control and monitoring procedures
analyzing chemical residuals are discussed.
References:
21 CFR Part 211
FDA Guide to Inspections of Validation of Cleaning Processes
Amendments to the current GMPs Regulations for Finished Pharmaceuticals: Final Rules
effective December 8, 2008
Guidance for Industry: cGMP for Phase 1 Investigational Drugs, July 2008
Principles of FDA Inspections for Pharmaceutical Manufacturers (PHA61)

This course reviews the basics of FDA inspections of drug Topics include:
manufacturing facilities, including authority, purpose, types and Scope of FDA inspections
areas/operations typically inspected. The course also reviews
Types of inspections
how companies and their personnel should generally handle FDA
How inspections are initiated
inspections and interact effectively with investigators.
Guidance for handling inspections
Areas the FDA will likely inspect
Interacting with the FDA
What happens at the end of an inspection
References:
FD&C Act, Chapter VII General Authority, Section 704 Factory Inspection
Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections Program
7356.002
Principles of Good Documentation (PHA74)

Documentation is an essential part of Good Manufacturing Topics include:
Practice (GMP). This course provides an overview for manufacturers Regulatory Requirements
of pharmaceutical and biological products of the documents Instructional Documents
required and the controls that should be in place. The regulatory
Records
requirements of FDA are addressed with reference also made to the
Control
requirements of the EU.
Electronic Documentation
The course provides an introduction to staff at all levels and Good Practices
highlights the personal responsibility they have for ensuring
documentation is followed and documentation is correct.
Requirements for Computerized Systems Validation and Compliance (ISPE01)

This course, the first in a four-part series, describes regulatory Topics include:
requirements and expectations regarding the validation and Computerized or automated systems
compliance of computerized systems used in the manufacture
Regulations addressing the requirements for validating
of pharmaceuticals, biologicals and medical devices. It does not computerized systems
cover the detailed requirements of 21 CFR Part 11, except the Three types of validation
requirement for systems to be validated. Even though it draws
How software differs from hardware
upon medical device guidance, it is not intended to cover all the
Guiding principles for computerized systems validation and
requirements of producing software that subsequently becomes
compliance
part of a medical device.
Installation Qualification (IQ), Operational Qualification (OQ)
and Performance Qualification (PQ) as related to computerized
systems validation
FDA expectations for validation activities and documentation
References: Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures Validation, FDA,
21 CFR Part 11 Electronic Records; Electronic Signatures August 2001 (Draft Guidance)
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals Guide to Inspection of Computerized Systems in Drug Processing, FDA ORA, February 1983
21 CFR Part 820 Quality System Regulation Guideline on General Principles of Process Validation, FDA, May 1987
GAMP 4: GAMP Guide for Validation of Automated Systems, ISPE, 2001 Software Development Activities, FDA ORA, July 1987
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA CDRH,
January 2002 Note: Content for this course is provided by the International Society of Pharmaceutical
Glossary of Computerized System and Software Development Terminology, FDA ORA, August 1995 Engineers (ISPE).
Resolving Out-of-Specification Test Results (PHA50)

Obtaining an Out-of-Specification (OOS) test result can be Topics include:
unsettling, and it is important that you know what to do with it. Out-of-Specification (OOS) test results
You will learn what the FDA says about handling batch or product
Purpose of a laboratory investigation
samples that indicate OOS results. You will also learn how to
Performing a formal investigation
evaluate suspect results and conduct preliminary investigations in
Use of averaging
response to OOS results.
Outliers
This course explains how to respond accordingly when an OOS What is required when an OOS result is determined to be valid
result is encountered. Mastering this content will enable you to
References:
know what to look for and what to investigate when an OOS 21 CFR Subpart I, Laboratory Controls;
Subpart J Records and Reports, Parts 211.192, and 211.194.
result occurs. It will also explain the cautions involved in handling FDA Guidance Document (draft): Investigating Out-of-Specication Test Results
for Pharmaceutical Production
data that may be related to OOS results, such as re-testing, FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories
averaging and outliers.
Review of Basic Statistical Techniques (DEV44)

This course will explore the proper use of statistical techniques Topics include:
as they apply to Medical Device manufacturing. More than just a Definition
set of mathematical tools, the use of statistics in Medical Device
Data Analysis
manufacturing is now expected and regulated by the FDA in the
Histograms
Quality System Regulation, Subpart O, Statistical Techniques.
Variability
References:
21 CFR 820.250 Statistical Techniques
Risk Management in Pharmaceutical Manufacturing (PHA72)

This course will cover the practical application of Risk
Management principles, published in Guidance for Industry:
Q9, through case studies applied to process design and
manufacturing.
Testing for Bacterial Endotoxins (PHDV86)

This course will provide a general overview of bacterial Topics include:
endotoxins and the methods used to test for their presence in Bacterial endotoxins
products. The specific techniques for conducting the gel-clot
Performing the gel-clot LAL test
Limulus Amebocyte Lysate (LAL) test will be presented, including
Chromogenic LAL assay
extensive discussion on standards and controls used. In addition,
Determining appropriate testing methods
variations to the gel-clot test will be presented, including the
chromogenic and kinetic alternatives, along with the advantages References:
The content in this course addresses key aspects of 21 CFR Parts 210, 211, and 314 - Applications for
and disadvantages of each method. FDA Approval to Market a New Drug, FDA Guide to Inspections of Quality Systems, and Part 820:
Medical Device Quality System Regulation.
The Design and Development of Software Used in Automated Process Controls (PHDV80)
Both the Pharmaceutical and Medical Device industries automate Topics include:
their manufacturing processes in order to make them more Automated process controls
efficient, more accurate and more consistent. As a result, the
Types of software used to automate processes
use of computerized systems has become common. This course
Software requirements
serves as an introduction to the design and development of
Design implementation and development
process-control software.
Software verification and software validation
Compliance requires that manufacturers apply the principles and Final two phases of the software development lifecycle
practices of software quality assurance to automated systems
References:
that may ultimately affect product safety and effectiveness. Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in
Pharmaceutical Manufacture, Volume 1, Parts 1 and 2, Volume 2, GAMP Forum, Version 3,
At the conclusion of this module you will be able to explain the March 1998
software development lifecycle, including basic verification and 1983 Guide to Inspection of Computerized Systems in Drug Processing (FDA)
1987 Guide to General Principles of Process Validation (FDA)
validation activities, and describe several aspects of software 21 CFR Part 211.68
21 CFR Part 11
quality assurance, including training and qualification of vendors. FDA Technical Report: Software Development Activities, July 1987
FDA Guidance for Industry: General Principles of Software Validation, June 1997
Understanding GMPs for Facilities and Equipment (PHDV63)

Facilities and equipment GMP requirements impact many aspects Topics include:
of plant operation from setup to maintenance and cleaning. This GMP regulations
interactive program introduces the general layout and equipment General GMP requirements for facilities
used within a Pharmaceutical or Medical Device manufacturing
Requirements for the cleanliness of facilities
plant.
Design of facilities to promote proper flow
References:
21 CFR Parts 210, 211 and 820 Equipment requirements
PHDV63-EU contains the same content as noted above and also includes these references:
EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Equipment maintenance
Part 1, Chapter 3 Premises and Equipment and Chapter 5 Production
EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Equipment calibration
Annex, 15 Qualication and Validation
Note: This course is also available in French.
Understanding Post-Approval Changes (PHA49)

This course covers the definition and purpose of post-approval Topics include:
changes (PAC). In addition, it explores the four categories of Defining post-approval changes
change: Components and Composition, Scale of Manufacture,
PAC guidance documents
Site of Manufacture, and Manufacturing and requirements for
Scale-Up and Post Approval Changes (SUPAC) guidance
each level of change. You will learn about PAC guidance and how
Components and composition category
these documents are used to provide notification to the FDA for
PAC to an approved drug application. You will examine the levels Site of manufacture category
of PAC and the recommended chemistry, manufacturing, and Scale of manufacture category
control (CMC) requirements for each level. You will also explore Manufacturing category
the categories of change. Finally, you will be able to identify
the tests and documents needed for each level and category of
change.
References:
21 CFR Part 314.70 FDA CDER, SUPAC-SS: Nonsterile Semisolid Dosage Forms: Scale-Up and Post-Approval Changes:
Federal Register Volume 64, No. 123, June 28, 1999, Supplements and Other Changes to an Approved Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence
Application Documentation
Guidance to Industry: Changes to an Approved NDA or ANDA, Food and Drug Administration FDA CDER, BACPAC I: Intermediates in Drug Substance Synthesis: Bulk Actives Post-Approval
Center for Drug Evaluation and Research (CDER), November 1999 Changes Chemistry, Manufacturing and Controls Documentation
FDA CDER, SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval FDA CBER, Guidance for Industry: Changes to an Approved Application for Specied Biotechnology
Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bio- and Specied Synthetic Biological Products, US Department of Public Health, FDA
equivalence FDA CBER, Guidance for Industry: Changes to an Approved Application, Biological Products, US
FDA CDER, SUPAC-MR: Modied Release Solid Oral Dosage Forms Scale-Up and Post-Approval Department of Public Health, FDA
Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bio- Changes to an Approved NDA or ANDA
equivalence Documentation
Understanding the Principles and Practices of Process Controls (PHA47)

Recently the FDA has become increasingly concerned with the Topics include:
number of Warning Letters being issued due to problems with the Validation
control of manufacturing processes. Items listed in these various
Equipments affects on process controls
Warning Letters include lack of validation of manufacturing
Batch production record
processes, lack of written procedures, improper sampling and
testing of materials and failure to follow written procedures.
Sampling and testing
Reprocessing
Contamination control
Change control
References:
21 CFR Parts 211.100-211.115 and 211.188
Vendor Certification for Pharmaceutical Manufacturers (PHDV85)

This course discusses the process of vendor certification a Topics include:
means of ensuring that a company is receiving the best possible Vendor certification process
materials, products and services from its vendors or suppliers.
Criteria for selecting vendors for certification
This course covers the common practices and concepts associated
Vendor audits
with vendor certification. After completing this course, you will
Testing
have a basic understanding of the value and process of vendor
certification. References:
For Drug Products: 21 CFR Part 211 Section 211.22 Responsibilities of the Quality Control Unit
21 CFR Part 211 Subpart E, Control of Components and Drug Product Containers and Closures
For Medical Devices: 21 CFR 211, Part 820 Quality System Regulation 21 CFR Subpart E, Section 820.50
Purchasing Controls
Writing and Reviewing SOPs (PHA48)

If you are directly involved in the manufacture and/or testing of Topics include:
a regulated product, chances are you are familiar with the role Standard Operating Procedures (SOPs)
Standard Operating Procedures (SOPs) play in helping to establish
GMP requirements for SOPs
a controlled manufacturing process. Understanding how SOPs
Elements of an effective SOP
are written and reviewed is an important insight into how quality
SOP design
products are manufactured. This course is designed to help you
understand and recognize the principles and practices applicable Components of a SOP
to written procedures. Youll learn the rationale and GMP Review and approval process
requirements for written procedures as well as the different types Document control
of procedures and how they are developed. Additionally, youll This course addresses requirements set forth in 21 CFR Parts 210, 211, 606, and 820
become familiar with the format and content of a procedure. Note: This course is also available in French.
Writing Validation Protocols (PHA51)

This course provides the learner with the information that should Topics include:
be included in a validation protocol. The learner is introduced What processes or systems require validation?
to the key components of the protocol, such as information
What is the basic format of a protocol?
related to materials, equipment, and acceptance criteria. This
What should be included in a validation protocol?
course is an introduction to the importance and content of the
documentation that comprises validation.
After completing this course, the learner will understand what

validation protocols are. The learner will also be able to identify
the three types of qualifications, as well as the properties of each
qualification. The learner will also be able to describe the key
elements involved in a validation protocol.
About UL EduNeering
UL EduNeering is a business line within UL Life & Healths Business Unit. UL is a premier
global independent safety science company that has championed progress for 120 years. Its
more than 10,000 professionals are guided by the UL mission to promote safe working and living
environments for all people.
UL EduNeering develops technology-driven solutions to help organizations mitigate risks,

improve business performance and establish qualification and training programs through a
proprietary, cloud-based platform, ComplianceWire.
For more than 30 years, UL has served corporate and government customers in the
Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance
management approach integrates ComplianceWire, training content and advisory services,
enabling clients to align learning strategies with their quality and compliance objectives.
Since 1999, under a unique partnership with the FDAs Office of Regulatory Affairs (ORA),
UL has provided the online training, documentation tracking and 21 CFR Part 11-validated
platform for ORA-U, the FDAs virtual university. Additionally, UL maintains exclusive
partnerships with leading regulatory and industry trade organizations, including AdvaMed,
the Drug Information Association, the Personal Care Products Council and the Duke Clinical
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What courses are listed in the library?

What courses are listed in the library?

What topics are covered in the course 'Understanding the Principles and Practices of Process Controls'?

What topics are covered in the course 'Understanding the Principles and Practices of Process Controls'?

LIBRARY GUIDE:

How to Meet Drug Retention and Stability Testing Requirements (PHA43) . . . . . . . . . . . . . . . . 18

Courses Listed by Functional Area:

Maintenance and Facilities Management/Supervision

R&D/Design Controls Inspections

Content is continually updated to reflect changes in these regulations. Using innovative

When the symbol appears within the course description, it indicates

symbol indicates that the content

A Tour of the FDA (PHDV60)

Application of GMPs to Analytical Laboratories (PHDV78)

Application of GMPs to Microbiology Laboratories (PHDV72)

Approach to Computerized Systems Validation and Compliance (ISPE02)

Awareness of FDA Inspections for Pharmaceutical Manufacturers (PHA65)

Batch Record Reviews (PHA53)

Biotechnology: An Overview of Compliance Considerations (PHDV68)

Change Control (PHA35)

cGMPs for Combination Products (PHDV93)

Collecting Samples and Establishing Limits for Cleaning Validation (PHA54)

Complaint Management for Pharmaceutical Manufacturers (PHA71)

Conducting Annual Product Reviews (PHA45)

Corrective and Preventive Actions (PHA70)

After completing this course, you will be familiar with applicable

DEA Compliance (PHA40)

Documenting Validation Activities (PHA55)

materials, processes and products, and personnel.

Effectively Responding to FDA 483s and Warning Letters (PHDV70)

Environmental Control and Monitoring (PHDV87)

Essentials of an Effective Calibration Program (PHDV75)

Failure Investigations for Pharmaceutical Manufacturers (PHA59-EU)

FDA Training and Qualification Requirements (PHA67)

GMPs for API Bulk Manufacturers (PHA52)

GMP Principles for Batch Records (PHA60)

GMP Principles of SOPs (PHA64)

GMP Updates Enforcement Changes at the New FDA (PHDV91)

Gowning for Sterile Manufacturing (PHA63)

GMP Updates: Supply Chain Quality and Emerging Compliance (PHDV92)

biologics and medical devices..

Handling a Product Recall (PHDV64)

Handling an FDA Inspection (PHDV74)

High Purity Water Systems (PHDV82)

for monitoring a water system, and possible methods of solving

How to Meet Drug Retention and Stability Testing Requirements (PHA43)

This course addresses the following:

ICH Q7A: Introduction and Quality Management (ISPE05)

ICH Q7A: Resources and Materials Management (ISPE06)

Implementing an Equipment Qualification Program (PHDV88)

After completing this course, you will be able to define equipment

Interviewing Techniques (FDA27)

Introduction to GMPs (PHA38)

Key Concepts of Process Validation (PHDV77)

Maintenance and Cleaning of Drug Manufacturing Equipment (PHA44)

Managing FDA Inspections for Pharmaceutical Manufacturers (PHA66)

Meeting GMP Training Requirements (PHDV76)

salvaged products, GMP requirements, acceptable practices and

Orientation to GMP Compliance (PHDV73)