Paul L.

Pluta and Troy Fugate

Effective Training
Paul L. Pluta and Troy Fugate

Training Welcome to “Effective GMP.”

Variation
Critical quality attributes

API QbR This column discusses specific GMP topics useful to practitioners in compliance
EMEA and validation. We intend this column to be a useful resource for daily work ap-

QbD
CALIBRATION
Change control
GHTF
plications. The primary objective for this column: Useful information.
The many and varied aspects of GMP, requirements for compliance, and the

PQ
Critical process parameters

ramifications of lack of compliance make addressing GMP topics a critical objective for
Product compliants this journal. Recent guidelines have addressed quality systems and risk analysis. These
Design space concepts will define the general approach to GMP compliance in the 21st century.
Deviations The key word describing our objective for this column is “effective.” Compliance
IQ FMEAProcessICH
design
professionals must accomplish the goals and requirements of GMP without excesses
Maintenance or waste—the cost of compliance is an important consideration. Understanding and
Quality systems
Validation

Risk analysis prioritizing the most critical elements of the various aspects of GMP is fundamental to
S. STEWART

WHOVerification
a successful organization.
“Effective GMP” addresses GMP topics with these challenges in mind. We intend
to present various GMP topics clearly and in a meaningful way so that our readers will
be able to understand and apply the principles discussed.
Reader comments, questions, and suggestions are needed to help us fulfill our
objective for this column. Please send your comments and suggestions to column
coordinator Troy Fugate at troy@compliance-insight.com or coordinating editor Susan
Haigney at shaigney@advanstar.com.

INTRODUCTION
The cornerstone of compliant operations in a US Food and Drug Adminis-
tration-regulated industry is properly trained personnel who successfully
perform their day-to-day functions according to approved procedures.
Training of personnel is a key element supporting successful performance.
Training that is well designed, conducted efficiently, and monitored for
effectiveness is fundamental to success. Prioritized and cost-effective train-
ing is especially important for obtaining support by senior management.
Senior management support is critically important in regards to personnel,
time, and resources allotted for training.
Training should be established in a manner that works for each particular
firm. No one program fits all, so these guidelines should be evaluated and
implemented in a manner to ensure success for the specific organization.

DISCUSSION
The following key considerations are necessary to
accomplish effective training:
• Training policy, standards, and procedures documented
• Training process strategy and approach defined
• Principles of adult learning theory considered
• Training needs analyzed and prioritized by risk analysis
• Collaboration of affected groups with defined responsibilities and
requirements for each group
• Trainees and their organizations are “customers” of training
• Training appropriate for task
• Training materials and methods appropriate and effective
• Qualified training personnel

32  Special Edition: A Roadmap to GMP Compliance Part 2


• Training performance
• Training effectiveness monitoring and
maintenance
• Change training if needed
• Training documentation
• Efficient and cost-effective training
• Senior management support training.
Training Policy, Standards, And Procedures
Documented
The organizational training program from high level
policy documents through working level procedures
should be documented. High-level documents should
include guiding principles and objectives as well as
compliance with relevant regulatory (FDA, Occupation-
al Safety and Health Administration, etc.) guidelines.
Training standards, including required documentation,
metrics, trainer qualifications, change control, etc.,
should also be specified. Training on working level pro-
cedures must be compliant with all high level policies
and standards. A consistent and repeatable approach
to training throughout all organization sites is desir-
able. All training process documents should be timely
maintained and be readily available.
Training Process Strategy And Approach Defined
The working level strategy and approach to training should
comprise a three-part sequence as follows:
• Training development including task analysis,
design, development, evaluation, trials, correction,
and so on
• Training of personnel using developed methods and
facilitated by qualified trainers
• Maintenance and monitoring, including changes
and improvements as indicated by performance
evaluation.
Principles Of Adult Learning Theory Considered
Training management and responsible personnel must
consider principles of adult learning theory in develop-
ment of training. The training of adults has specific
considerations, and these must be known and taken
into account in order to develop effective training for an
adult audience.
Training Analyzed And Prioritized by Risk Analysis
Risk analysis should be conducted to ensure that the
level and extent of training conducted is appropriate and
commensurate with the criticality and complexity of the
task performed. The more critical and complex the task
(e.g., aseptic manufacturing), the greater the time and
effort required in training.
Collaboration Of Affected Groups
Training must be a collaborative effort between affected
groups. Affected groups are the organizational func-
Paul L. Pluta and Troy Fugate
tion, the training function, and the trainees. Each of the
affected groups provides input to the training process
and has the following requirements, responsibilities,
and needs:
• Organization function. The organization func-
tion requires trainees to be able to perform required
tasks. The organization function must commu-
nicate clear expectations for trained personnel to
the training function. The organization function
is the customer of the training group. Tasks to be
performed must be clearly identified. Appropriate
training (e.g., classroom, demonstration, on-the-job
[OJT], etc.) should be recommended.
• Training function. The training group requires
clear training expectations from the organization
function. The training group requires resources
and time to accomplish the expectations of the op-
erations function. The training group is responsible
for development of training materials and methods,
and for qualified trainers to perform training. Mem-
bers of other organizations may serve in training
function (i.e., experienced operators may serve as
OJT trainers).
• Trainee. Trainees should be able to perform required
tasks after training is completed. Trainees require
efficient use of their time and useful training materials
and methods. Trainees must provide effort and dedi-
cation to the training program and must be appropri-
ately engaged in the training process.
Trainees And Their Organizations Are Customers Of
Training
The training group should approach their responsibil-
ity as if the trainees and their organizations are the
customers of training. Training must be effective (i.e.,
the training function must do a good job) as evaluated
by the trainees and their organizations.
Training Appropriate For Task
Task analysis should be performed to determine the
discrete steps of a procedure that will ensure acceptable
job performance. Task analysis evaluates the organiza-
tion, facility, employee, and specific task (1).
Training Materials And Effective Methods
Training materials and methods must be carefully designed
and developed. Subject matter experts must be available
and approve training materials as needed. Training must
be appropriate to the task and level of training required.
Depending on the task analysis, training may be classroom
training or OJT training (2). After the training material has
been developed, trial runs should be conducted to evaluate
the developed module before full implementation and
routine usage (3).
Qualified Training Personnel
Special Edition: A Roadmap to GMP Compliance Part 2 33
Paul L. Pluta and Troy Fugate
Trainers must be qualified regarding basic knowledge,
experience, communication skills, and interactive skills.
Trainers must be appropriate for the situation (i.e., OJT
trainer must be skilled and experienced in the activity
they facilitate), as well as have the ability to communi-
cate their expertise. The approach and effort expended
to qualify trainers should be analogous to that for quali-
fication of equipment and facilities (4).
Training Performance
Training must be conducted with well developed
materials and methods by qualified trainers. Person-
nel should ideally be trained in their native language,
either by procedures written in their native language
or by trainers fluent in their native language. Training
proficiency should be assessed (5).
Training Effectiveness Monitoring And Maintenance
Effectiveness should be monitored long term. Modifica-
tions in training materials should be implemented as
indicated by trained personnel performance. For exam-
ple, after observation of trained personnel performance,
certain aspects of training may need greater emphasis.
Remedial training should be conducted as appropriate.
The 2008 FDA process validation draft guidance recom-
mends tracking of operator errors to measure the quality
of the training program (6).
Change Training If Needed
If monitoring indicates the need to modify the training,
do so as soon as possible. Failing to react quickly hurts
the organization, violates the principles and objectives
of the training effort, and damages the reputation of the
training group.
Training Documentation
All aspects of training must be documented (7). Docu-
mentation must consider the needs of the organization
(i.e., trained personnel documentation), as well as the
likelihood of audit by internal groups and outside regula-
tory agencies.
Efficient And Cost-Effective Training
Any waste associated with training must be minimized.
Senior management will not support training that is not
efficient and cost-effective.
Senior Management Support
Senior management requires personnel to be able to per-
form required tasks through cost-effective and compliant
training programs. Senior management must provide
resources, time, and personnel to the training function
to accomplish training. Senior management should
demonstrate leadership in support of training. Resourc-
es, cost, and time must not limit the training function.
The tangible support of senior management is critical to
34  Special Edition: A Roadmap to GMP Compliance Part 2
the success of the training function.
CONCLUSIONS
This discussion addresses key elements of training
in support of current good manufacturing practice
compliance. Although training is a required activity, it
should also be subjected to cost and benefit analysis. It
is a cost to the organization insofar as it uses resources
that could be applied elsewhere. Training should be
conducted efficiently, effectively, and appropriately to
reduce costs and increase benefits. Use of risk analysis
is recommended to appropriately prioritize training
efforts.
In brief, key elements of training involve the orga-
nization; strategy and approach of the training group;
collaboration of affected organizational groups; devel-
opment of training materials, methods, and trainers;
training performance, monitoring and maintenance;
documentation; and senior management support of the
training effort. The support of senior management in
personnel, time, and resources is critical to the success
of the training function.
ACKNOWLEDGMENT
The authors thank Gordon Welty for helpful discus-
sion and comments.
FUTURE COLUMNS
Future discussions of “Effective GMP” will address
topics such as material storage, documentation
practices, contract services, batch record review, and
other topics. Suggestions for future discussion topics
or questions to be addressed are requested from the
readers. Please send suggestions to column coordi-
nator Troy Fugate at troy@compliance-insight1.com
or coordinating editor Susan Haigney at shaigney@
advanstar.com.
REFERENCES
1. Welty, Gordon, “Strategy and Tactics of Task Analysis,” Journal of
GXP Compliance, Volume 11, #3, April 2007.
2. Welty, Gordon, “The ‘Design’ Phase of the ADDIE Model,” Jour-
nal of GXP Compliance, Volume 11, #4, July 2007.
3. Welty, Gordon, “Strategy and Tactics for Pilot Implementation
in the ADDIE Model,” Journal of GXP Compliance, Volume 12, #2,
January 2008.
4. Ross, Malcolm, Journal of GXP Compliance, Volume 13, #1, Win-
ter 2009.
5. Welty, Gordon, “Developing Assessments of Trainee Proficiency,”
Journal of GXP Compliance, Volume 12, #1, October 2007.
6. FDA, Process Validation: General Principles and Practices, Draft
Guidance, November 2008.
7. Welty, Gordon, “Strategy and Tactics of Training Recordkeeping,”
Journal of GXP Compliance, Volume 12, #3, Spring 2008. GXP

ARTICLE ACRONYM LISTING
FDA US Food and Drug Administration
GMP Good Manufacturing Practice
OJT On-the-Job Training
ABOUT THE AUTHORS
Paul L. Pluta, Ph.D., has more than 30 years of pharmaceutical
industry experience and is the editor-in-chief of the Journal of GXP
Compliance and the Journal of Validation Technology. He can be reached
by e-mail at paul.pluta@comcast.net.
Originally published in the Summer 2009 issue of Journal of GXP Compliance
Paul L. Pluta and Troy Fugate
Troy Fugate is the vice president of Compliance Insight, Inc. Troy
works with companies regionally and worldwide in the pharmaceu-
tical and biotechnology industries in the fields of compliance and
quality assurance. His consulting realm includes parenteral, tablet,
capsule, oral liquid, nutraceutical, device, diagnostic, and API regula-
tion compliance. Troy’s primary strengths are quality assurance
activities with emphasis in quality systems, risk assessment, and
systemic audits. Troy can be reached by e-mail at troy@compliance-
insight.com.
Special Edition: A Roadmap to GMP Compliance Part 2 35