A Risk-based Approach to GMP Training:

One Size Does Not Fit All

David C. Markovitz
“Training in current good manufacturing • Does it include those working off
practice shall be conducted by qualified shifts – evenings, nights, weekends?
individuals on a continuing basis and
with sufficient frequency to assure that An annual refresher GMP course
employees remain familiar with cGMP developed as a one size fits all approach
requirements applicable to them.” This may be easy to design and administer,
is the current wording of 21 CFR Part but it is an approach fraught with danger.
211 Subpart B, Section 211.25 Consider the risks involved.
(Personnel Qualifications).
• Someone whose job directly
How is your organization interpreting deals with exposed product may
and applying this section of the not learn enough about GMP
regulation? Many companies interpret requirements to prevent
this to mean something like – “We contamination, mix-ups, or errors
conduct annual GMP training for our from occurring.
production employees.” Or it may even
be interpreted as – “We conduct annual • Someone whose job is far
GMP training for all of our employees.” removed from exposed product
may be burdened with learning
GMP regulations that have no
• Is this adequate? bearing or impact on their specific
• Will an annual dose of GMP training responsibilities.
for some of your employees be • Someone who was off the job
acceptable to FDA? Will an annual due to disability, maternity leave,
dose of GMP training for all of your jury duty, or even vacation may
employees be acceptable? miss the training session.
• Does all employees include • Contract employees may miss the
temporary employees? training altogether if they are not
• Does it include consultants or on the official company roster.
contractors? • Temporary employees may get
• Does it include custodial staff, if too little training to ensure the
your custodial operations are safety of your products.
outsourced?
This article will help you develop a
• Does it include members of the GMP training approach that meets the
security force, if the security service regulatory requirements and addresses
is outsourced? this from a risk-based perspective.
• Does it include maintenance Deciding who requires what training is
personnel? critical to getting started. Who should

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A Risk-based Approach to GMP Training – One Size Does Not Fit All
David Markovitz 714-289-1233 [email protected] p. 1 of 7 pp.
develop and conduct the training is attained by attendance at courses
another key component of a successful offered by industry providers. The
GMP training process. American Society for Training and
Development (ASTD) can offer
guidance here.
Who should develop and • A demonstrated aptitude for
conduct the training? teaching and training. There are
several instruments available to
The regulation states that “Training in assist in this determination.
current good manufacturing practice • A passion for teaching. This is
shall be conducted by qualified tough to objectively measure, but
individuals.” What are the can often be detected by the level
qualifications of a GMP trainer? A of enthusiasm an individual shows
qualified trainer is certainly someone when talking about this endeavor.
who has done more than read through
the regulations. It is certainly someone Most successful GMP training processes
who has done more than worked in the utilize a combination of inside and
operation for a long time. outside resources. It’s important to have
company employees teach aspects of the
It’s highly suggested that your company regulatory requirements. It demonstrates
start by listing the qualifications required that “We believe in these regulations,
to teach GMP in the organization. and our policies and procedures are
Perhaps even develop a job description aligned to comply with them.”
for a GMP trainer. Depending upon the Employees of the company can also
size of your company, this does not have clearly demonstrate how the company
to be a full-time position. It can be policies and procedures address each
duties associated with another job title. aspect of the regulations. A sound
The important thing here is to document objective of any GMP training process
the qualifications. should be to gain the commitment of all
employees to comply with the
Some suggestions for qualifications regulations and all company policies and
include: procedures. Too often, training sessions
• Experience working in the appear aimed at coercing employees into
industry – a minimum of five years compliance. I have experienced that by
is recommended. focusing on efforts to gain commitment
among the workforce, compliance comes
• Extensive knowledge of the GMP along naturally.
regulations. This is best attained
by attendance at GMP seminars The efforts of your internal delivery of
and courses offered by many GMP training should be augmented with
industry providers. the use of outside experts. It’s amazing
• Knowledge and demonstrated how the credibility and status of your
expertise of adult learning theory internal trainers goes up after employees
and techniques. This is best are exposed to training by the outside

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A Risk-based Approach to GMP Training – One Size Does Not Fit All
David Markovitz 714-289-1233 [email protected] p. 2 of 7 pp.
expert. There’s something unique about • Are they willing to work with you
hearing the facts from an outsider, to customize the training?
especially if it’s information that you’ve
• Are they willing to do the research
heard from your internal trainer. It’s a
required to ensure that the training
way to validate the knowledge and
they develop and conduct
credibility of your internal training force.
reinforces your internal themes and
An outside expert can also lead your
messages?
people in discussions regarding leading
issues within FDA, something internal
An outside expert in GMP training
people may not have the time or
should be considered as a partner in your
resources to do. An outside expert also
GMP training process. Your internal
comes free of any “organizational
and external GMP training team can
baggage” which may negatively impact
ensure that you have a state-of-the-art
the learning process.
training process, and that your
employees are getting the right dose of
Choosing an outside expert to help with
training when they need it.
your GMP training process should be
carefully considered. Here’s some
questions to help you select the right
expert. Who gets the training and how
much should they get?
• Do they have the technical
knowledge? The regulation states that “Each person
• Have they worked in industry? engaged in the manufacture, processing,
packing, or holding of a drug product
• Do they have hands-on experience shall have education, training, and
in being on the receiving end of an experience, or any combination thereof,
FDA inspection or customer audit? to enable that person to perform the
• How well can they connect with assigned functions. Training shall be in
and relate to your employees? the particular operations that the
employee performs and in current good
• Do they have good presentation manufacturing practice as they relate to
skills? (or are they a lecturer? the employee’s functions.” (21CFR Part
Lecturing is a surefire method for a 211 Subpart b, Section 211.25)
disastrous GMP training event –
face it, regulatory training is not the So the short answer is EVERYBODY IN
most exciting topic, but it DOES THE COMPANY needs GXP training.
NOT have to be boring.) Everyone working for the company is
• Do they know how to design and engaged in the manufacture, processing,
deliver an interactive training packing, or holding or a drug product in
session? some fashion. A clerk in Accounts
Payable could impact the relationship
• Are they willing to coach and with a supplier of a critical raw material.
mentor your internal training An Information Systems analyst could
people? impact the operation of critical software

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A Risk-based Approach to GMP Training – One Size Does Not Fit All
David Markovitz 714-289-1233 [email protected] p. 3 of 7 pp.
used in the manufacturing process. A • What is the probability of someone
sales person could make promises to a in this position contaminating our
customer that could impact the product? (An accounting clerk
production schedule. A service working in a building one hundred
technician may discover valuable data in miles from the manufacturing site
the field that could lead to product has no chance of contaminating a
improvements. A security officer may product. A shipping clerk who
leave a door ajar that could impact the handles finished packages before
safety and efficacy of a batch of product. they are shipped has some chance,
We could write a scenario for every job while an operator working in the
in your organization and how that job is filling room has a high chance of
ENGAGED in the manufacture, contaminating a product.)
processing, packing, or holding or a drug
• What is the impact on quality of a
product.
mix-up by someone in that
position?
Now the question is - What level of risk
does this job have on the quality of • What is the impact on quality of an
our products? error by someone in that position?

It’s important to identify the level of risk The table below demonstrates how one
for each job title in your company. Keep can graphically display and organize
it simple by identifying High, Medium, these into High, Medium, and Low risk
and Low risk for determining the level situations. This table is presented for
of GMP training required. Start by demonstration purposes only – your
asking the following questions. actual situation will determine the risk
level for each job. (Table 1 Job Titles
• To what extent does this job
and Level of Risk)
impact the safety and efficacy of
our products?

HIGH MEDIUM LOW

Sterile Fill Room Operator X
Accounts Payable Clerk X
Production Supervisor X
Information Systems Analyst X
Security Officer X
Human Resources Benefits Administrator X
Quality Control Analyst X
Receiving Clerk X
Shipping Clerk X
Compounder X
Scheduler X
Payroll Clerk X
Cafeteria cook X
Table 1 Job Titles and Level of Risk

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A Risk-based Approach to GMP Training – One Size Does Not Fit All
David Markovitz 714-289-1233 [email protected] p. 4 of 7 pp.
Completing this table shouldn’t take “Training in current good manufacturing
long. It’s best done by an ad-hoc team practice shall be conducted on a
of subject matter experts (internal people continuing basis and with sufficient
with knowledge about these positions). frequency to assure that employees
To make the task simpler, create a table remain familiar with cGMP
for each department. For instance, a requirements applicable to them.”
table for Materials Management could
be created. In this table you might have
positions such as Scheduler, Receiving How frequent should we conduct
Clerk, Shipping Clerk, Material GMP training?
Handlers, Purchasing Manager,
Purchasing Clerk, and others. The answer is IT DEPENDS. It depends
Determining level of risk also depends on the risk factor. It only stands to
on their proximity to products being reason that those positions with a higher
processed. The Purchasing people may level of risk should get training more
be in a separate building and never frequently. Keeping people fresh is
actually enter the building where paramount if the level of criticality is
products are manufactured or stored. A high. Commercial airline pilots have to
Receiving or Shipping Clerk may have be re-certified in their jobs every six
to walk through a packaging area in months. Are only the bad pilots called
order to get to their work areas. in for re-certification? Of course not.
Knowing policies and procedures for the All pilots are required to pass the re-
packaging areas would become an certification process.
important part of their training, where it
would not be for the Purchasing people. The employees of the airlines who check
us in at the gate or handle our baggage
The objective is to design “the right have a different dose of training and re-
dose” of training for each position. training for their positions. Sending
Several positions can be combined based someone’s bags to the wrong location,
upon their level of risk and their general although irritating to us passengers, does
job responsibilities. Starting with the not carry the same risk level to the
premise that every employee receives a passengers as a pilot who reacts too
certain dose of GMP training as part of slowly or overreacts when caught in a
their new employee orientation, we can wind shear situation.
use the tables to determine what follow-
up training is required and how Sufficient frequency of GMP training for
frequently to conduct that training. someone working inside a sterile filling
area, a position with a high-risk level,
Of course, those positions with higher might be interpreted as once each month.
risk levels should be accorded more in- This can be a formal GMP training
depth training and more frequent session with an instructor and handouts
training. Guarding against complacency, or workbooks. Another month it may be
or “rustiness on the job,” is the main a portion of a department meeting
reason the regulation stipulates that dedicated to discussing GMP issues,
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A Risk-based Approach to GMP Training – One Size Does Not Fit All
David Markovitz 714-289-1233 [email protected] p. 5 of 7 pp.
with a Supervisor presiding. It may be Document the training
specific GMP lessons embedded into a
game show format during a particular Make sure to document each training
month. It may be a guest speaker from a session. There are several commercially
different department. It may be a formal available training documentation
class with an outside expert. It may be software packages available. Make sure
something slightly different each month. you use one that can provide the
As long as it’s planned as part of an appropriate reports. The biggest benefit
overall training process, the delivery of preparing reports is in keeping track
method may vary. In fact, it should of who has received what training. This
vary, not only to keep it interesting, but can be quite a task with peoples’
also to appeal to the different learning vacation schedules, jury duty absences,
styles among those attending the and other absences due to illness, family
training. leave, disability, and other reasons
people miss work. Scheduling people to
Consider someone who may work in attend the make-up sessions is easier
Human Resources as a Benefits with the proper reporting structure in
Administrator and their risk level is low. place.
Perhaps their office is in a separate
building and they have no authorization This documentation also provides proof
to enter any building where product is to FDA that you have a training process
either manufactured or stored. What is in place that is working. Your risk
sufficient frequency of GMP training for assessment training tables are also useful
this person? The general GMP training to show to FDA during an inspection as
provided in the new employee further proof that you have a well-
orientation process may be sufficient for designed GMP training process that uses
this position, unless there are changes to the risk-based approach.
the regulations or the company’s policies
and procedures. An annual workshop on
GMP may be desirable to ensure that Training as a Process
these folks continue their vigilance of
working in the health care industry. Viewing your GMP training activities as
a process, and not just a series of events,
This training should focus on how their can help you ensure an ongoing
specific responsibilities impact and commitment throughout the
affect the commitment to GMP organization. Determining different
throughout the company. Using the levels or “doses” of training geared to
example of Benefits Administrator, specific groups is the best course of
consider the impact on employee morale action.
of changes to employee benefits. Poor
morale often increases the probability of One size does not fit all.
mix-ups and errors throughout the work
force.

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A Risk-based Approach to GMP Training – One Size Does Not Fit All
David Markovitz 714-289-1233 [email protected] p. 6 of 7 pp.
Specific targeted training is more their colleagues. How much training
effective over the long term. Basic they receive and how frequently they
introductory courses addressing all three receive it depends on many factors.
risk levels should be part of someone’s Using the risk-based approach is a
training plan when they join the simple and easy to implement method to
company. They then can enter the design and manage this process.
process of on-going GMP training with

David Markovitz, Founder and President of GMP Training Systems, Inc., helps
companies in the Life Sciences industries improve their overall performance,
productivity, and profits. He does this by consulting on Business Survival Skills
for FDA regulated industries, and by conducting workshops on topics ranging
from GMP/QSR to Leading Change and Innovation and Process Optimization.
An award winning speaker and workshop leader, David develops and conducts
training sessions that get rave reviews as well as results. He has over three
decades of management experience in FDA regulated industry. David is the
author of Becoming the Best: Making Optimization Happen, GMP Makes Good
Business Sense, The Team Process Improvement Workbook, and the 212
Optimization Tips booklet. David can be reached at 714-289-1233 and by e-mail
at [email protected].

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A Risk-based Approach to GMP Training – One Size Does Not Fit All
David Markovitz 714-289-1233 [email protected] p. 7 of 7 pp.