Developing A Train-the-Trainer Program For Regulatory Compliance Part II

5/1/2017 Developing
a TraintheTrainer Program for Regulatory Compliance Part II
Published on IVT Network (http://www.ivtnetwork.com)
Developing a TraintheTrainer Program for Regulatory Compliance
Part II
By Gordon Welty, Ph.D. Nov 25, 2013 10:14 am PST
Peer Reviewed: Training
Abstract
This paper is the second of two parts that discuss the development of a trainthetrainer (TTT) program for
regulatory compliance. This part focuses on the content of such a TTT program. It addresses the various topics
that are presented in the classroom session in greater detail. These topics include good manufacturing practice
(GMP) and other compliance issues: adult learning theory, effective communication, crosscultural competence,
delivery skills (including both classroom training and structured onthejob training [SOJT]), conducting
presentations (again, both classroom training and SOJT), and, finally, the ADDIE model and program design.
Following the classroom session, the aspiring trainers will participate in a qualification session wherein their
proficiency can be demonstrated in utilizing the seven major topics mentioned above. Should the aspiring trainer
not successfully complete the TTT qualification session, remediation will focus on the areas of writing behavioral
objectives, focusing on compliance issues, the importance of having a training plan, and determining effective
delivery methods.
Introduction
Thispaper is the second of two parts that discuss the development of a trainthetrainer (TTT) program for
regulatory compliance. The first part focused on the foundations of such a TTT program, addressing the
processes involved in preparing for, conducting, and documenting the various sessions that make up the TTT
program—the initial classroom training session, followed by the qualification session, then various remediation
sessions that may be necessitated if an aspiring trainer is not successful in completing the classroom or
qualifications session.
This part focuses on the content—rather than the process—of such a TTT program. It addresses the various topics
that are presented in the classroom session in greater detail. These topics include good manufacturing practice
(GMP) and other compliance issues: adult learning theory, effective communication, crosscultural competence,
delivery skills (including both classroom training and structured onthejob training [SOJT]), conducting
presentations (again, both classroom training and SOJT), and, finally, the ADDIE model and program design.
Following the classroom session, the aspiring trainers will participate in a qualification session wherein their
proficiency in utilizing the seven major topics mentioned above can be demonstrated. If the aspiring trainer does
not successfully complete the TTT qualification session, remediation will focus on the areas of writing behavioral
objectives, the need to focus on compliance issues, the importance of having a training plan, and determining
effective delivery methods.
The Content of a TTT Classroom Session
http://www.ivtnetwork.com/print/article/developingtraintrainerprogramregulatorycompliancepartii 1/12
5/1/2017 Developing a TraintheTrainer Program for Regulatory Compliance Part II
There are seven major components that make up the content of the TTT classroom session. These include:
GMP and other compliance issues
Adult learning theory
Effective communication
Crosscultural competence
Delivery skills (classroom and SOJT)
Conducting presentations (classroom and SOJT)
The ADDIE Model and program design.
The qualified trainer—the trainer who successfully completes this TTT classroom session as well as the TTT
qualification session that follows—will be able to integrate the content of all these components into the various
training modules that will subsequently be rolled out by the training unit (1).
These seven major components will now be discussed in some detail.
GMP Mindset, GMP Culture, and Other Compliance Issues
The TTT classroom session will discuss GMP requirements and other compliance issues and how they relate to
the defined training process. Any training must impact on three levels: the GMP mindset, which is the individual
employee’s commitment to GMP compliance in each aspect of his or her work every hour of the work day; the
GMP culture, which is the work group’s reinforcement of GMP compliance for every employee within that group;
and other compliance issues that encompass the relationship between GMP compliance and other compliance
regimes such as Occupational Safety and Health Administration (OSHA), Drug Enforcement Administration
(DEA), etc. (2).
The importance of training in the pharmaceutical industry can be understood in terms of four factors.
Proficiency in both cGMP and technical operations demands training. The employee must be trained in his or
her tasks as well as cGMP, and the trainer must be a “qualified individual.” Training records are routinely reviewed
in regulatory audits to determine if the employee has an appropriate curriculum (i.e., an individual training plan
[ITP]), whether the employee has been trained in the current version of all relevant SOPs as listed in the ITP, and
whether the employee has participated in the most recent continuing GMPrefresher training.
Every activity in the pharmaceutical manufacturing and laboratory process requires accountability and
traceability. Every batch record has to meet specifications as detailed in continuously refined and updated SOPs
and has to be signedoff and countersigned. Employees are trained on the importance of this to their work.
All activities in the pharmaceutical industry are documented. Production records, equipment maintenance
logs, and laboratory test records are legal documents. Operators and analysts must be trained in completing
these documents per appropriate SOPs.
Good business practice demands training. Given trained employees, manufacturing and laboratory processes
are more reproducible. Given appropriate training, employees can troubleshoot and solve problems. With trained
employees, rework, recalls, and other waste are lessened. Finally, trained and skilled employees contribute to
startup activities and process development.
These points about GMP and other compliance issues will be conveyed to the aspiring trainers during the TTT
classroom session.
Adult Learning
The TTT classroom session will discuss established adult learning principles, including the significance of the
adult learner’s experiential base, how it can facilitate or obstruct effective training, and the need for clear
expectations on the part of the adult learners (3).
According to Malcolm Knowles, adult learning differs substantially from that of children and adolescents. Children
tend to let others decide for them while adults tend to decide for themselves.
Among the characteristics of adult learning, Knowles stressed:
Adults want to solve problems.
Adults want to apply new knowledge immediately.
Adults are ready to learn when they assume new roles.
Adults draw upon their reservoir of experience for learning.
Adults want to move from dependency to selfdirectedness (4).
Moreover, adults learn best when they are at ease. They have trouble learning ideas that conflict with their
opinions, values, or prior experiences. Adults learn best when they have clear expectations. Each of these points
has immediate implications for training. What are some of these implications? Discussions should be relaxed
rather than stressful. Informality should prevail rather than formality. The trainer should emphasize that there are
no right or wrong answers. The trainer should make both the trainees’ and organization’s expectations clear at
the beginning of the training session (5).
Above all, the trainer should treat trainees as adults.
The TTT classroom session will communicate all of these points to the aspiring trainers.
Communication Skills
The TTT classroom session will address effective methods of communication that enable the trainer to assume a
leadership role in the session. Skills ranging from communication techniques and utilizing questions to effective
group management will be addressed.
There are four specific skills for successful communication between a trainer and the trainees. These include
coaching, questioning techniques, feedback, and motivation. In each case, the trainer is interacting with the
trainee(s).
Coaching, for instance, can help trainees to improve by communicating specific behaviors that need change or
reinforcement. It can help trainees to continue to grow by praising a job well done, and, through coaching, the
trainer can show concern for trainees’ needs and goals (6).
Questions are a fundamental means of back and forth communication. They can be used to check the trainee(s)
level of engagement with the content of the session. They can increase the trainee(s) interest level and break
monotony.
There are several types of questions, including the group question, the direct question, the redirect question, and
the return question; each type can take a specific form, including openended questions, closeended questions,
and leading questions.
In the group type of question, the trainer asks the whole group. This type of question is useful to open a
discussion, to introduce a new phrase, or to give everyone an opportunity to talk. Examples would include, “What
would you do in this situation” or “How would you explain such and such.”
In the direct type of question, the facilitator directs a question to a specific member of the trainees preceded by
that member’s name. This type of question can serve to call on a person for specific information or to involve
someone who has not yet participated in the discussion. Examples would include, “Frances, how many
contractors work at your site?” or “Frank, how did you handle your last group of contractors?”
When the trainer redirects a question, a question from one participant to the facilitator is redirected to another
participant. This type question can help the trainer avoid giving an opinion, it can bring others into the discussion,
and it can let the trainer call on someone who knows the answer. An example includes, “Can anyone suggest a
different way to handle this?” Another example is, “What does anyone else think about this?” Again, an example
would be, “How would you answer that, Fran?”
Finally, the return question is when the trainer volleys a question from a participant back to that same participant.
This type question can help the trainer avoid giving an opinion, it can encourage the questioner to think, and it
can bring out opinions from others. Examples include, “How would you define that?” or “There is no one answer
to that question; what answers occur to you?”
The trainer has a responsibility to really listen to the response: encourage the trainee to keep talking; focus on
what the other is saying; use good nonverbals to show you’re listening; let the other person finish talking.
Feedback is communicating your observations and assessments to another person. Feedback should be specific
and directed. The trainer should say, “I noticed you had some difficulty with that job. Is there something I can
clarify for you?” The trainer should not say, “You’re doing that job all wrong.” (7).
Motivation is identifying the person’s need and encouraging him or her to attain a desired benefit or goal.
Motivating a trainee can focus on trainees’ achievement, participation, and recognition. Concerning achievement,
trainees want to know they’ve achieved something. Concerning participation, trainees want to feel as though
they’re an important part of the team or organization. Concerning recognition, trainees want to be recognized for
their accomplishments (8).
In communicating with the trainees, the trainer should practice feedback and motivation techniques. The trainer
should effectively use the training opportunity; it is precious, limited training time.
All this material will be communicated to the aspiring trainers during the TTT classroom session.
CrossCultural Competence
It is becoming increasingly clear—as the workforce in the United States becomes increasingly ethnically diverse
—that a qualified trainer must be crossculturally competent. What is crosscultural competency? For the purposes
of the TTT program, this can be defined as the ability of trainers to respond respectfully and effectively to members
of all cultures, races, classes, ethnicities, and religions in order better to achieve objectives of the training process
(9).
Crosscultural competency can be practiced at three levels: the organizational level, the professional level, and
the personal level.
Organizational crosscultural competency involves a management committed to diversity. Crosscultural
competency is valued, supported, and evaluated from the top down: training in crosscultural competency is
supported for staff, cultural and linguistic diversity is pursued in staffing, and skills and resources are in place to
support a culturally diverse set of trainees.
Professional crosscultural competency involves the development of crosscultural competence standards by the
training profession, thereby, making crosscultural competency an important part of professional education and
development and providing guidance for working lives of individual training professionals
Personal crosscultural competency involves trainers developing appropriate knowledge, attitudes, and skills
towards cross cultural competency; being supported to work with a culturally diverse set of trainees; and
developing relevant, appropriate, sustainable cross culturally competent training programs.
Delivery Skills
The TTT session will show how to conduct training using a lesson plan and other training materials in both the
classroom and in a structured OJT setting.
There are three “P’s” to keep in mind for developing the trainer’s delivery skills:
Plan
Prepare
Practice.
The training plan, sometimes called the lesson plan, tells what to say and when to say it, indicates the type and
timing of interactive events, and provides information on training materials to use. In particular, regarding a
specific training session, the training plan specifies:
The behavioral objectives
The training content
The instructional methods
The assessment checklists
The necessary documentation of the training session.
The advantages of a training plan include a consistency of material presented and an identical sequence of
training. It will ensure that learning activities are completed and at the correct time.
Training materials should always be appropriate to the training activity being conducted.
They should also provide variety. Finally, the trainer should always have a Plan “B.” Training materials include:
PowerPoint Slides
Overhead transparencies
Flipcharts and markers
Whiteboards
Video/Audio
Handouts
Plan “B.”
The training setting can be either a classroom setting or an onthejob setting. The advantage of a classroom
setting is that essentially all techniques and materials are available for use. It is a controlled environment.
However, there are also disadvantages to a classroom setting. There is a very limited possibility of handson
training unless the classroom especially configured.
In a classroom setting, always examine the suitability of the training materials. Go to the worst seat in the house
and see if you can read the screen. If you can’t, enlarge the fonts! Also, determine the acoustics. Can you hear
questions that are presented from every seat in the room? If not, get several standup microphones for the
trainees.
A structured OJT setting also has advantages and disadvantages. A prime advantage is the possibility of using
handson techniques in the training session. Among the disadvantages are the uncontrolled environment is
uncontrolled and limited availability of equipment.
The trainer might want to consider a blended approach wherein part of the training session takes place in a
classroom setting and the rest takes place in an onthejob setting.
Finally, after the training plan has been developed, the training materials are prepared, and the training setting
selected, the trainer should practice delivering the training session. The trainer should ensure that everything
works as planned, and the trainer should anticipate questions from the trainees.
Content of TTT Classroom Presentations
The TTT classroom session will show how to conduct presentations to various audiences in several training
environments for both OJT and classroom training.
Preparatory Steps in Training
The trainer will analyze the job, trainees, and the organization. Then the trainer will develop a training plan—an
organized description of steps that will be taken in the training session. Typically the training plan includes the
following four elements:
Behavioral objectives of the training session
Content (the script)
A list of instructional methods to be used
A set of assessment measures to ascertain if the trainee(s) have successfully achieved the training
session objectives.
Behavioral Objectives express the results to be achieved in this training session. The behavioral objectives do
not describe what the trainer does during training. Rather, they describe a task or skill the trainee will be able to
demonstrate at the end of a successful training session.
The behavioral objectives must be expressed in action words.
Table I: Acceptable and Unacceptable Action Words.
Acceptable Action Words: Unacceptable Action Words:
Identify Understand
Label Know
Locate Appreciate
Operate Become
Run Grasp
Install Improve
Prepare Learn

Demonstrate
Content is the subject matter of the training. It is derived from the objectives (results desired). If a behavioral
objective states, “At the end of the training, the trainee will be able to load an autoclave,” then the content of the
training session will engage the trainee in loading an autoclave.
Instructional Methods are the training activities the trainer uses to achieve the behavioral objectives.
Instructional methods are derived from the behavioral objectives. If a behavioral objective states, “At the end of
the training, the trainee will be able to use the double bucket method of cleaning,” then the instructional method
will involve using two buckets, a mop, cleaning solution, etc. Examples of instructional methods include the
lecture, individualized selfstudy (either computerized or text based), oneonone coaching, and the observation
of others.
Assessments are checklists derived from the behavioral objectives.
Preparing the Trainee
Preparing the trainee means establishing a good relationship between the trainee, the trainer, and among the
trainee(s). It means placing the trainee at the workstation (for OJT). It means building the trainee’s motivation.
As the trainer is establishing good interpersonal relations, he or she should find out about the trainee(s). Trainers
should introduce themselves, ask the trainee(s) to do the same, and “make small talk” to set learner at ease. The
trainer should show enthusiasm for the training task.
As the trainer is placing the trainee at the workstation, he or she should place himself or herself next to the trainee
at the workstation. This is called “sidebyside training.” Avoid “barriers”—desks, chairs, equipment, etc.—
between trainer and trainee during structured OJT.
The trainer should take steps to avoid interruptions during the training session.
Conducting Structured OJT
If the training session is structured OJT, then there are four steps to be followed:
Table II: The Four Steps of Structured OJT.
Explain the tasks to the trainee Tell
Demonstrate the tasks Show
Ask the trainee to perform the tasks and observe performance Do
Follow up with the trainee Follow Up
The most important steps in structured OJT are:
Tell the trainee what to do.
Show the trainee what to do.
Ask the trainee to do the task.
Follow up with the trainee.
This simple training model is based on a timeproven method, has been thoroughly tested, and has been shown
to increase productivity.
The first step is telling the trainee what to do by explaining the SOJT task:
What task to perform or what results are expected.
Describe what to do.
Avoid specialized jargon.
Describe task in sequence of performance.
Note: Onthejob trainers (such as supervisors or long service employees) often know too much about the subject
to be able to structure information for someone who knows very little or nothing about it. This is one reason the
training plan is so important. It sets boundaries on what the trainer will be conveying to the training audience.
The second step is to show the trainee what to do. Demonstrate the tasks:
The trainer should demonstrate the “right way” to do the task.
Emphasize the most important steps.
Describes the reason why the task is done the way it is.
Learning through observation is a major way of learning.
Provide good examples. Remember that “short cuts” are not GMP!
The third step in structured OJT is to ask the trainee to perform the tasks and observe performance. The trainer
should observe the trainee’s performance closely. The trainer should resist the urge to help. Allow the trainee to
complete the task before providing feedback.
The final step in structured OJT is to follow up with the trainee. Effective feedback is delivered promptly. Effective
feedback is clear and unambiguous.
At the close of the structured OJT presentation, the trainer will make clear what documentation is involved in
completing the training session.
Program Design: ADDIE
The TTT session will include an overview of the systematic process of developing and designing new training
modules based on the ADDIE model, the industry standard used in to ensure consistency and integrity while
sustaining validity and reliability of training (10). Familiarity with the ADDIE model is critical for the qualified
trainer, in part, because this model helps the trainer as new training modules are being developed and, in part,
because the model is the industry standard.
Training is a response to the identification of a performance gap. Once a performance gap has been identified,
the training program design process includes five phases characterized in terms of the acronym ADDIE:
Analysis of training needs, situation, and tasks.
Design: write behavioral objectives.
Developing training materials and assessment materials.
Implementation (pilot).
Evaluating the program: refining.
The first phase is to analyze the performance gap to ascertain what training is needed. The trainer should
analyze the training needs that the proposed training module will address, analyze the situation within which the
training will occur, and analyze the tasks that are involved.
Next, the trainer should design the training module that will address the training needs. This preliminary program
will be sketched in a training outline (TO) per the appropriate SOP. It is critical that the trainer writes behavioral
objectives as part of the TO. Behavioral objectives specify the competencies that the trainees will demonstrate
after successfully completing the proposed training. Behavioral objectives are a checklist for assessing the
success of the training. They should be explicitly required in the GMP training unit’s SOPs.
A template for a training outline follows; this illustrative template has twelve fields and instructions for completing
each field (11).
Table III: Training Outline Template.
Fields Instructions
1. COURSE TITLE: Enter the title of the document or course.

2. COURSE Enter the number and version of the procedure, protocol, or document.
NUMBER and
VERSION:
3. TRAINING Those required job positions included in the scope of the learning product.
AUDIENCE: Identify the areas, departments, and positions. For example, a training
audience may consist of:
All managers in a department
All managers and supervisors in an area
All employees in a department
All employees who operate the bottler on Packaging Line 84.
4. CURRICULUM FIT Identify the training module or other associated courses
5. PREREQUISITE List any prerequisite courses or any required skills
COURSES/
REQUIRED SKILLS
6. TRAINERS: All qualified trainers who have been identified as SMEs on the course,
including the originator and business owner if they are qualified trainers.
7. BEHAVIORAL Specify the observable competencies that trainees will demonstrate upon
OBJECTIVES: completing the training. For example, “At the end of this training session,
the trainee will be able to demonstrate the following skills or perform the
following tasks…”
8. TRAINING Check as appropriate:
DELIVERY
Classroom
METHOD:
Structured onthejob training
Computerbased training, etc.
9. COURSE Enter the approximate time required to deliver the training session. This
LENGTH: information is for planning purposes only.
10. SPECIAL Instructions to facilitate the preparation and execution of the event (e.g.,
INSTRUCTIONS: safety issues, logistical requirements, prework, handouts, etc.)
11. MEASURES of The KTA (and answer sheet) or SDA should be attached. The content of the
EFFECTIVENESS: KTA or SDA is derived from the behavioral objectives.

12. Includes signatures from
APPROVAL:
Originator
Department management and/or business owner
Quality unit.
In the third phase, development, the training module is created and approved. This product integrates the training
materials—trainee activities, instructional content, delivery methods, and instructional technologies—and the
assessment materials to close the performance gap.
There are four components of the development phase:
Identifying the objectives of the learning product based on the relevant procedure and the training outline
Preparing the training materials to address those objectives
Preparing the assessment materials
Assembling these materials into the training module.
The first step in preparing training materials is to identify the “hook,” the stimulus that will get the trainee’s
attention. An effective hook will pull the trainee into the training event and ensure that the trainee is engaged in
with the activities that will lead to the behavioral objectives of the training module.
The second step is to prepare the script—the content—for the training module. This script can take the form of
talking points or complete discourse; in either case, the script highlights the training stimuli that lead to the
behavioral objectives.
A third step is to select the training media. As noted above, these might include PowerPoint slides, flipcharts and
markers, a white board, various video and audio selections, handouts, etc.
The trainer will also develop assessment materials for the training module. As noted above, behavioral objectives
should be mandated in the training unit’s SOPs. These are the basis of a KTA checklist or a skill demonstration
(SDA) checklist. Training effectiveness is assessed by one of these measures—a KTA or a SDA (12).
The KTA in particular need not be validated in terms of the task(s) at hand. If the KTA is validated, then
performance improvement onthejob can be predicted from trainee performance on the KTA. If the KTA has not
been validated, the measure can still be included in the learning product as an interactive element of the
courseware and as a promissory note of future validation, if you will. The training event will be concluded in this
case by the trainee (and trainer) concurrence that the trainee was trained on this courseware and thereby on the
SOP. An SDA, by contrast, directly and validly documents the trainee’s ability independently to perform the task(s).
Furthermore, once the relevant SDAs for a process are completed, the trainee is qualified and therefore able to
independently perform the tasks in that process.
Implementation (as a pilot) is the fourth phase of the ADDIE model. If the training module that the trainer has
developed seems to be efficacious, say in terms of face validity and peer review, it becomes a candidate for pilot
implementation. Following the directions in the training outline, the trainer will assemble the training and
assessment materials. Next the trainer schedules and conducts of the pilot event per the training unit’s SOPs.
The pilot has several outcomes. It shows that the promising solution can be scaled up in general (or not). The pilot
shows the validity and reliability of the specific interpersonal and institutional process selected for the pilot (or
perhaps it shows unreliability). It generates process and outcome data that may be important for the finalized
training module. Furthermore, it provides data on cost and scheduling considerations that should be taken into
account in the wider rollout to the whole organization.
The final phase is to evaluate the new training module. The trainer will review the pilot trainees’ assessments
(KTAs or SDAs), review the interactive elements in the new training event, and review the behavioral objectives,
assessment materials, and documentation of the training event. Then the trainer will revise the training and
assessment materials as necessary.
The preceding discussion has covered the seven major components of the TTT classroom session. Next, the
content of the TTT qualification session will be presented followed by the content of the refresher TTT session.
Content of a TTT Qualification Session
The TTT qualification session is where the aspiring trainer makes a training presentation to demonstrate mastery
of the seven elements of good GMP training:
GMP and other compliance issues
Adult learning theory
Effective communication
Crosscultural competence
Delivery skills (classroom and SOJT)
Conducting presentations (classroom and SOJT)
The ADDIE Model and program design.
The ideal performance would design the entire presentation within the ADDIE framework with clearly stated
behavioral objectives and then conduct the presentation effectively, discussing GMP and other compliance
issues, all the while showing an awareness of adult learning theory, effective communication (with a lot of
questions for the audience), good delivery skills, and a sensitivity to crosscultural issues.
Content of a Refresher TTT Session
There are four objectives to a refresher TTT session. These objectives have emerged as the main problem areas
that aspiring trainers have when seeking qualification. At the successful conclusion of the session, the trainee will
be able to:
Identify and state behavioral objectives
Focus on compliance issues
Describe the importance of having a training plan
Determine effective delivery methods.
Throughout the refresher session, the trainees should assume the role of qualified trainers, as though they had
successfully completed the qualification session. Moreover, they must think in terms of a hypothetical training
session that they might be conducting.
Writing Behavioral Objectives
The trainee must be able to specify the training goals and objectives for the hypothetical training session:
Be precise in specifying the goals and objectives. What is intended as the outcomes of this hypothetical
training session?
Use action words—focus on performance.
Keep the goals and objectives simple.
Use measurable goals and objectives.
Keep goals and objectives to a minimum.
Here are some examples of behavioral objectives:
At the end of this (hypothetical) training session, the trainee will be able to write behavioral objectives that:
Identify ________________.
Perform ________________.
Install _________________.
Prepare ________________.
Focus on Compliance Issues
The second topic for the TTT refresher session is the focus on compliance issues, especially GMP compliance.
This focus involves a review of the GMP mindset, the GMP culture, and other compliance issues, including the
regulatory overlap between GMP regulations and DEA, Environmental Protection Agency (EPA), and OSHA
regulations. It also involves a review of business compliance issues.
The Training Plan
The third topic is the importance of having a training plan. This is the trainer’s roadmap. The training plan
specifies the behavioral objectives. It tells what to say and when to say it. It indicates the type and timing of
interactive events. It provides information on training materials to use.
Effective Delivery Methods
Our fourth topic is having effective delivery methods—for both the classroom and the OJT settings. Effective
delivery methods involve selecting media that will deliver the most effective training. A critical point for effective
delivery is to never read directly from the SOP!
Conclusion
This paper is the second of two parts that discuss the development of a train the trainer (TTT) program for
regulatory compliance. The first part focused on the foundations of such a TTT program, addressing the
processes involved in preparing for, conducting, and documenting the various sessions that make up the TTT
program—the initial classroom training session, followed by the qualification session, and then various
remediation sessions that may be necessitated if an aspiring trainer is not successful in completing the classroom
or qualifications session.
This part focused on the content of such a TTT program. It addressed the various topics that are presented in the
classroom session, including GMP and other compliance issues, adult learning theory, effective communication,
crosscultural competence, delivery skills, conducting presentations, and, finally, the ADDIE model and program
design.
Following the classroom session, the aspiring trainers will participate in a qualification session in which they can
demonstrate proficiency in utilizing the seven major topics mentioned above. If the aspiring trainer does not
successfully complete the TTT qualification session, remediation will focus on the areas of writing behavioral
objectives, the need to focus on compliance issues, the importance of having a training plan, and determining
effective delivery methods.
Taken together, this twopart discussion clarifies the elements and steps that are necessary to develop a TTT
program for regulatory compliance. Meeting the requirements of compliance is a serious responsibility in
pharmaceutical and life sciences industry, placing a substantial burden on training resources; a welldeveloped
and implemented TTT program can go a long way to alleviating those staffing requirements economically.
References and Notes
1. The first component, GMP and Other Compliance Issues, can be replaced by different regulatory regimes
such as DEA, Environmental Health and Safety (EHS), good laboratory practice (GLP), OSHA, etc. This
allows the overall framework to be applied to any regulatory TTT program. For an example of a TTT
program focusing on OSHA regulations, see B. Levin, “Making TraintheTrainer Programs More Effective,”
Material Handling Management 55 (6), 2000.
2. G. Welty, Quality Assurance, Woodbridge Publishing Ltd., Cambridge, UK, 2013.
3. G. Welty, “What Are Adult Learning Principles?” Journal of GXP Compliance 14 (2), 819, 2010.
4. M. Knowles, The Modern Practice of Adult Education, Prentice Hall, Englewood Cliffs, NJ, 1980.
5. R. Zemke and S. Zemke, “Thirty Things We Know for Sure About Adult Learning,” Innovation Abstracts 6
(8), 1984.
6. B.M. Bass and R. Stogdill, Handbook of Leadership. Theory, Research & Managerial Applications, Free
Press, 3rd ed., New York, 1990, ff; also Audrey Besson Levíne, “The Importance of Being Coached,”
Financial Management, 5053, 2012.
7. M. London and J. Smither, “Feedback Orientation, Feedback Culture, and the Longitudinal Performance
Management Process,” Human Resource Management Review 12 (1), 81100, 2002, also Deborah
Busser, “Delivering Effective Performance Feedback,” T + D 66 (4), 3235, 2012.
8. C. Musselwhite, “Creating a Culture of Motivation,” T + D 65 (9), 4649, 2011.
9. C.M. HampdenTurner, Building CrossCultural Competence, Yale University Press, New Haven, CT,
2000. While the present point is the inclusion of a cross cultural competency component within a TTT
program, it is intriguing that programs have been developed to use a TTT program to disseminate the
content of cultural competency; see M. Assemi, et al. “Evaluation of a TraintheTrainer Program for
Cultural Competence,” American Journal of Pharmaceutical Education 71 (6), 18, 2007.
10. G.R. Morrison, Designing Effective Instruction, Wiley, New York, NY, 6th ed., 2010.
11. For a more extensive discussion of the Training Outline, its fields and instructions, see G. Welty, Quality
Assurance, op. cit., pp. 125130.
12. See also K. Ellis “The Right Track,” Training 41 (9), 4046, 2004).

Source URL: http://www.ivtnetwork.com/article/developingtraintrainerprogramregulatorycompliance
partii

Developing A Train-the-Trainer Program For Regulatory Compliance Part II

Uploaded by

Copyright:

Available Formats

You might also like

Developing A Train-the-Trainer Program For Regulatory Compliance Part II

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Developing A Train-the-Trainer Program For Regulatory Compliance Part II

Uploaded by

Copyright:

Available Formats

5/1/2017 Developing

You might also like