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Paul L.

Pluta and Troy Fugate

Effective Training
Paul L. Pluta and Troy Fugate

Training Welcome to “Effective GMP.”

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-

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

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
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

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

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 or coordinating editor Susan
Haigney at

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.

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

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Paul L. Pluta and Troy Fugate

• Training performance tion, the training function, and the trainees. Each of the
• Training effectiveness monitoring and affected groups provides input to the training process
maintenance and has the following requirements, responsibilities,
• Change training if needed and needs:
• Training documentation • Organization function. The organization func-
• Efficient and cost-effective training tion requires trainees to be able to perform required
• Senior management support training. tasks. The organization function must commu-
nicate clear expectations for trained personnel to
Training Policy, Standards, And Procedures the training function. The organization function
Documented is the customer of the training group. Tasks to be
The organizational training program from high level performed must be clearly identified. Appropriate
policy documents through working level procedures training (e.g., classroom, demonstration, on-the-job
should be documented. High-level documents should [OJT], etc.) should be recommended.
include guiding principles and objectives as well as • Training function. The training group requires
compliance with relevant regulatory (FDA, Occupation- clear training expectations from the organization
al Safety and Health Administration, etc.) guidelines. function. The training group requires resources
Training standards, including required documentation, and time to accomplish the expectations of the op-
metrics, trainer qualifications, change control, etc., erations function. The training group is responsible
should also be specified. Training on working level pro- for development of training materials and methods,
cedures must be compliant with all high level policies and for qualified trainers to perform training. Mem-
and standards. A consistent and repeatable approach bers of other organizations may serve in training
to training throughout all organization sites is desir- function (i.e., experienced operators may serve as
able. All training process documents should be timely OJT trainers).
maintained and be readily available. • Trainee. Trainees should be able to perform required
tasks after training is completed. Trainees require
Training Process Strategy And Approach Defined efficient use of their time and useful training materials
The working level strategy and approach to training should and methods. Trainees must provide effort and dedi-
comprise a three-part sequence as follows: cation to the training program and must be appropri-
• Training development including task analysis, ately engaged in the training process.
design, development, evaluation, trials, correction,
and so on Trainees And Their Organizations Are Customers Of
• Training of personnel using developed methods and Training
facilitated by qualified trainers The training group should approach their responsibil-
• Maintenance and monitoring, including changes ity as if the trainees and their organizations are the
and improvements as indicated by performance customers of training. Training must be effective (i.e.,
evaluation. the training function must do a good job) as evaluated
by the trainees and their organizations.
Principles Of Adult Learning Theory Considered
Training management and responsible personnel must Training Appropriate For Task
consider principles of adult learning theory in develop- Task analysis should be performed to determine the
ment of training. The training of adults has specific discrete steps of a procedure that will ensure acceptable
considerations, and these must be known and taken job performance. Task analysis evaluates the organiza-
into account in order to develop effective training for an tion, facility, employee, and specific task (1).
adult audience.
Training Materials And Effective Methods
Training Analyzed And Prioritized by Risk Analysis Training materials and methods must be carefully designed
Risk analysis should be conducted to ensure that the and developed. Subject matter experts must be available
level and extent of training conducted is appropriate and and approve training materials as needed. Training must
commensurate with the criticality and complexity of the be appropriate to the task and level of training required.
task performed. The more critical and complex the task Depending on the task analysis, training may be classroom
(e.g., aseptic manufacturing), the greater the time and training or OJT training (2). After the training material has
effort required in training. been developed, trial runs should be conducted to evaluate
the developed module before full implementation and
Collaboration Of Affected Groups routine usage (3).
Training must be a collaborative effort between affected
groups. Affected groups are the organizational func- Qualified Training Personnel

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Paul L. Pluta and Troy Fugate

Trainers must be qualified regarding basic knowledge, the success of the training function.
experience, communication skills, and interactive skills.
Trainers must be appropriate for the situation (i.e., OJT CONCLUSIONS
trainer must be skilled and experienced in the activity This discussion addresses key elements of training
they facilitate), as well as have the ability to communi- in support of current good manufacturing practice
cate their expertise. The approach and effort expended compliance. Although training is a required activity, it
to qualify trainers should be analogous to that for quali- should also be subjected to cost and benefit analysis. It
fication of equipment and facilities (4). is a cost to the organization insofar as it uses resources
that could be applied elsewhere. Training should be
Training Performance conducted efficiently, effectively, and appropriately to
Training must be conducted with well developed reduce costs and increase benefits. Use of risk analysis
materials and methods by qualified trainers. Person- is recommended to appropriately prioritize training
nel should ideally be trained in their native language, efforts.
either by procedures written in their native language In brief, key elements of training involve the orga-
or by trainers fluent in their native language. Training nization; strategy and approach of the training group;
proficiency should be assessed (5). collaboration of affected organizational groups; devel-
opment of training materials, methods, and trainers;
Training Effectiveness Monitoring And Maintenance training performance, monitoring and maintenance;
Effectiveness should be monitored long term. Modifica- documentation; and senior management support of the
tions in training materials should be implemented as training effort. The support of senior management in
indicated by trained personnel performance. For exam- personnel, time, and resources is critical to the success
ple, after observation of trained personnel performance, of the training function.
certain aspects of training may need greater emphasis.
Remedial training should be conducted as appropriate. ACKNOWLEDGMENT
The 2008 FDA process validation draft guidance recom- The authors thank Gordon Welty for helpful discus-
mends tracking of operator errors to measure the quality sion and comments.
of the training program (6).
Change Training If Needed Future discussions of “Effective GMP” will address
If monitoring indicates the need to modify the training, topics such as material storage, documentation
do so as soon as possible. Failing to react quickly hurts practices, contract services, batch record review, and
the organization, violates the principles and objectives other topics. Suggestions for future discussion topics
of the training effort, and damages the reputation of the or questions to be addressed are requested from the
training group. readers. Please send suggestions to column coordi-
nator Troy Fugate at
Training Documentation or coordinating editor Susan Haigney at shaigney@
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- REFERENCES
tory agencies. 1. Welty, Gordon, “Strategy and Tactics of Task Analysis,” Journal of
GXP Compliance, Volume 11, #3, April 2007.
Efficient And Cost-Effective Training 2. Welty, Gordon, “The ‘Design’ Phase of the ADDIE Model,” Jour-
Any waste associated with training must be minimized. nal of GXP Compliance, Volume 11, #4, July 2007.
Senior management will not support training that is not 3. Welty, Gordon, “Strategy and Tactics for Pilot Implementation
efficient and cost-effective. in the ADDIE Model,” Journal of GXP Compliance, Volume 12, #2,
January 2008.
Senior Management Support 4. Ross, Malcolm, Journal of GXP Compliance, Volume 13, #1, Win-
Senior management requires personnel to be able to per- ter 2009.
form required tasks through cost-effective and compliant 5. Welty, Gordon, “Developing Assessments of Trainee Proficiency,”
training programs. Senior management must provide Journal of GXP Compliance, Volume 12, #1, October 2007.
resources, time, and personnel to the training function 6. FDA, Process Validation: General Principles and Practices, Draft
to accomplish training. Senior management should Guidance, November 2008.
demonstrate leadership in support of training. Resourc- 7. Welty, Gordon, “Strategy and Tactics of Training Recordkeeping,”
es, cost, and time must not limit the training function. Journal of GXP Compliance, Volume 12, #3, Spring 2008. GXP
The tangible support of senior management is critical to

34  Special Edition: A Roadmap to GMP Compliance Part 2

Paul L. Pluta and Troy Fugate

Troy Fugate is the vice president of Compliance Insight, Inc. Troy

ARTICLE ACRONYM LISTING works with companies regionally and worldwide in the pharmaceu-
FDA US Food and Drug Administration tical and biotechnology industries in the fields of compliance and
GMP Good Manufacturing Practice quality assurance. His consulting realm includes parenteral, tablet,
OJT On-the-Job Training 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
ABOUT THE AUTHORS systemic audits. Troy can be reached by e-mail at troy@compliance-
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

Originally published in the Summer 2009 issue of Journal of GXP Compliance

Special Edition: A Roadmap to GMP Compliance Part 2 35