Train the Trainer Guide for FDA Regulated Companies

Train the Trainer Guide Book:
For FDA Regulated Companies
compiled and edited by
MITCHELL W. MANNING Sr.
Updated August 3, 1994
And again on June 2, 2015
Why: To share the training legacy of a gifted, talented, and motivated team from all disciplines and levels in
the best company in the best of times for the pharmaceutical industry dedicated to the mission to qualify each
employee to contribute to the work of ensuring the identity, strength, purity, and quality of all their
pharmaceutical products.
How To Use: As Needed

Table of Contents
On The Job Train the Trainer Course
Example: Training Action Plans
Example: Training Customer Survey
Example: The Huge Curve Ball
Example: Training Tasks and Projects after the Curve Ball
Example: Training Statistics
Example: Training Action Plans
Example: Technical Training and Qualification Procedure
Example: Training, Testing, and Follow-up Procedure
Example: CGMP Training Procedure
Example: Qualification and Requalification of Employees Procedure
Example: Administration of Operating and Administration Procedures
Example: Writing Operating and Administration Procedures
Example: Training Records and Information Administration Procedures
Example: Training Attendance Documentation Form
Example: Job Description for Training
Example: Training Duties and Responsibilities by Job Title
Example: Status Update Report for Training
Procedures Analysis Handbook

ON-THE-JOB-TRAINING AND ASSESSING
TECHNIQUES
DAY ONE
8:00 a.m. Course Introduction, Agenda/Logistics, Participant Introductions, Course
Objectives
Defining On-The-Job-Training and Assessing Techniques
What we know about Adult Learning Theory
Why and How Adults Learn
10:00 a.m. Break
10:20 a.m. Characteristics of On-The-Job-Training
11:00 a.m. Developing Training Plan and Materials
12:00 a.m. Lunch
1:00 p.m. Developing Training Materials (continued)
Conducting On-The-Job Training
2:00 p.m. OJT Practice Training
4:00 p.m. Adjourn
DAY TWO
8:00 a.m. OJT Practice Training
12:00 p.m. Lunch
1:00 p.m. OJT Practice Training
2:00 p.m. Next Steps
3:00 p.m Adjourn

OJT COURSE OBJECTIVES
ON-THE-JOB TRAINING AND ASSESSING TECHNIQUES
A workshopfor subject matter experts (SMEs)to enhance their ability to
transfer their understanding of job responsibilities to other people.
PURPOSE
To improve the training effectiveness ofsubjectmatter experts in one-to-one
or small group training settings by providing logicaland systematic training
techniques and skills .
LEARNING OUTCOMES
Understand and apply adult learning principles
Distinguish betweenknowledge and skill(education vs. training)
Developsystematic teaching methods for OJT
Developtraining plans
Developa working model for OJT
Apply procedures to actualhands-on skills

ADVANTAGES of OJT
Provides consistentmethods of procedure training and retraining of skills
Aids the employee in "Getting it right the first time"
Aids in time management, and productivity of work force ultimately
leading to customersatisfaction
Aids in the continuous improvement and feedback process
Aids in setting of performance standards and criteria for job tasks
Develops training expertise among those closestto the work to be
performed

OJT DESIGN PROCESS
Identify Job
Analyze job
Identify critical job responsibilities
Identify required knowledge, skills and abilities.
Identify education, training and experience needs
Selectpotential job performer
Determine training and practice needs
Identify Subject MatterExpert(s)
Designinstruction
Developtraining plan
Prepare Subject MatterExpert(s) to teachand assess
Document SME qualifications
Deliver training
Evaluate results
Document and file results

OJT LEARNING PROCESS
Motivate by showing relevancyto job success
TransferUnderstanding
Evaluate for understanding
Involve in a Practicalapplication
Provide feedback
Involve on the job
Show results on the job

INFLUENCING LEARNING
Comfort
Confidence
Competence
Credibility
Commitment
PRACTICE
Describe things that you can do to influence learning for eachof the
"5 c's."

TRANSFER UNDERSTANDING
Awareness
Belief
Comprehend
Do

SYSTEMATIC TEACH FOR OJT
What Provide the overview of the job responsibility
A short statement of the job responsibility to be covered
List the equipment and procedures in sequence
Identify the education, training and experience required
Identify the knowledge, skills and abilities required
Why Provide the motivation
A short statement of the value of the job responsibility
How Provide the content knowledge
Prepare the trainee
Present the training
Reinforce the training
Example Provide a demonstration
Short and specific
Easily understood
Test For Understanding
Complementary Critique
Levels of Competence
Test and teach to competence
-Relate this to another job responsibility
-Identify the importance of this responsibility
-Analyze the impact of good and bad performance
Application Involve trainee on-the-job
Short review of what, why and how
Do it normal, Do it slow, Do it together, Then let'em go
First time assessment on-the-job
Transition
Quick review what and why
Explain assessment and agree on follow-up
Set target date for qualification and documentation

ON-THE-JOB TRAINING
a Skill, e.g., operating a piece of equipment
an Art e.g., playing the piano or guitar
the knowledge andability to apply a procedure or process, e.g., filling out a
check requisition form
PRACTICE
Give examples from work (eg. Voice Mail, Computer Log-on)

EDUCATION VS. OJT
Education focuses onthe instructor; OJT focuses onthe trainee.
Educationaltesting measures the student; OJT tests measure program
effectiveness,the trainer and the trainee.
Education accepts distribution of learning; OJT requires all trainees to do
well.
Education is intended to serve the student; OJT is intended to serve the
organization.
The student is responsible for learning in Education;the trainer/subject
matter expert is responsible with OJT.
With education learning is the solution to a myriad of problems; OJT is
sometimes only a partial solution.
With education there is a belief that learning is always good;sometimes
OJT can be harmful

HOW ADULTS LEARN
Involvement
SuccessatLearning
Big Picture
Task Structure

WHY ADULTS LEARN
Desire for Reward
Fearof Punishment
Curiosity

ADVANTAGES OF OJT
Time
Less Interference With Operations
Actual Working Conditions
Economics
Subject MatterExperts
PRACTICE
Describe how eachof the advantages canalso be a disadvantage and how to
turn them into advantages.

OJT vs CLASSROOM TRAINING
DIFFERENCES
Communication
Environment
Distractions
Instructor - Student
Trainer - Trainee
SIMILARITIES
GoodCommunication
Transferof Knowledge

POTENTIAL PROBLEMS WITH OJT
No clear cut process orstructure
Procedure not broken down into steps
No effective wayto evaluate results
Forgetto inform all necessaryfacts
Trainer doesn't know how to train

INSTRUCTIONAL DESIGN PROCESS
1. ANALYSIS
2. DESIGN
3. DEVELOPMENT
4. DELIVERY
5. EVALUATION

TYPES OF ANALYSES
Needs analysis
Job Analysis
Learner analysis

OTJ EFFECTIVENESS
THE KEY IS NOT
What you want to present
How you want to present it
What techniques you will use
THE KEY IS
Knowing behavioral objectives
Knowing required learning outcomes

WRITING OJT OBJECTIVES
1. Task Statement
2. Conditions
3. Performance Standard
PRACTICE: Decide which are good OJT objectives
1. Using a controlled sample of 50 vials, the trainee will be able to correctly
identify and record7 defects within 1 minute.
2. The trainee will know how to operate the bundler efficiently.
3. Given a set of circumstances, the trainee will be able to make a log book
entry in compliance with company standards.
4. From a tablet analysis report with 20 readings, the trainee will be able to
correctlycalculate the tablet weight mean and standard deviation.
5. Given a copy of the secretariesmanual, and a handwritten letter, the
trainee will type a business letter according to company standards.
6. Participants will learn to identify product defects.
SEQUENCING OJT CONTENT

1. Follow the normal sequence
2. Teachpre-requisite tasks first
3. Start with the most difficult task
4. Start with an enjoyable task

DETERMINING OJT SEQUENCING
1. What is the trainee ready for?
2. Which steps are easiest: and which are more complex?
3. Is there any step that is the center of interest?
4. Which steps provide skills or knowledge essential to other steps?
For example,
Select Prepare Sketch Paint Prepare
theme paints construction subject frame
lines
Select Prepare Paint Seal Mount
canvas canvas background surface painting
PRACTICE
Pretend you are about to instruct someone to serve as a temporary back-up to you in your current
job. List your critical job responsibilities.
Review the four factors above. Which factor most applies to each job responsibility?

OJT Practice Exercises and Materials
Anytime a step requires acquisition of a skill or application, in-depth instruction should be
followed by practice before going on to the next step.
Example:
Step 1 Step 2 Step 3 PRACTICE Step 4
Daily-life Obvious, Use of Obvious,
skill simple resource not simple
application familiar to application
of daily-life participants of resource
skill
PRACTICE
If your participants have no experience with woodwork tools or carpentry, where would you
insert practice?
Drill holes Screw 4 Nail bottom Solder pins nail
where marked sides together in place into holes top
PRACTICE
If participants have experience with woodwork, carpentry and the tools required, except for
soldering - where would you insert a practice exercise?
Drill holes Screw 4 Nail bottom Solder pins nail
where marked sides together in place into holes top
PRACTICE
Select a simple job responsibility. Break it into steps. Determine where you would insert
practice. Describe a practice activity and how you would assess the trainees understanding and
ability to perform the job responsibility.

OJT JOB AIDS
Job aids are devices used frequently to complement OJT. A job aid may take the
form of such things as a printed checklist, a step-by-step manual, or a plastic
measuring wheel. Whatever its form, the job aid provides on-the-job information
and instruction.

GUIDELINES FOR USING JOB AIDS
WHEN TO USE
Use job aids for instructions in:
Infrequently performed tasks, whether simple or complex. For example,
performing a simple calculation or assembling complicated testing equipment.
Infrequently performed tasks involving high risk to either the employee or
expensive equipment. Forexample, operating a fire extinguisher near highly
flammable materials.
Tasks that are complicated or that have many steps. For example, filing a
federal income tax return
Tasks that require close attention to detail because of risk to either the employee
or expensive equipment. Forexample, preparing an airplane for flight.
Tasks with frequent changes in performance. Forexample, tasks relying on
rapidly changing technology.
WHEN NOT TO USE
Job aids are not always appropriate. Use some other method of instruction, not a
job aid, for:
Tasks requiring quick responseor quick completion. For example, assembly
line tasks.
Situations where using a job aid could have a negative effect on customers. For
example, performing service tasks that a customer would expect the company
technician to know by heart.

CONSTRUCTING OJT JOB AIDS
Analyze the job responsibility in question to determine whether a job aid is
appropriate. Base your analysis on the "When to Use" and "When Not to Use" lists.
If a job aid is appropriate, follow these construction steps:
Determine whether the task should be supported by a job aid alone or by a job
aid and some other instructional method. Base your decision on the amount of
information recall needed to perform the task, the complexity of the task, and
the skills required in using the job aid.
- If recall is needed, instruction and practice in recalling information are needed
in addition to the job aid.
- If the task is complex, demonstration and practice in performing the task with
the job aid are necessary.
- If using the job aid is skill in itself (such as using a able of numbers or a
resource manual), training in that skill is needed.

Determine the main performance requirement for the task. Choosefrom these
requirements:
- Making decisions that are complex but that involve no sequence. For example,
"Take order if request is for first version of product, no matter what quantity is
requested. Take order for second version of productif quantity requested is less
than five: otherwise refer caller to marketing division. . ."
- Making decisions within a sequence. For example, "Press #1 on system,
requesting go-ahead. If receive, press SEND button. If do not receive go-ahead,
press RETRY.
- Making decisions leading to alternate sequences. Forexample, "If contents of
test tube turn green, follow these steps . . ."
- Following a sequence that involves no decisions. For example, "Lift receiver.
Press RECALL. Dial 115. Listen for three short tones. . ."
Decide format for the job aid. It can be anything from a wallet-size card to a
desktop printed stand to a stick-on label for equipment. Ask questions such as
these:
- How will the job aid be used? Forexample, will the employee be sitting at a
desk or walking around while using the job aid?
- How often will the job aid be used: Must it be built to last through frequent use?
- Will the job aid go with particular piece of equipment? Forexample, will the
job aid consist of operating instructions that should be affixed to the
equipment?

Write text for the job aid. Include these elements:
- Name of the job responsibility.
- Who should use the job aid.
- When to use the job aid.
- How to use the job aid.
- Any assumed conditions or prior events necessary for using the job aid.
- Any equipment or supplies necessary for using the job aid.
Follow these writing guidelines:
- Write clearly and specifically. Use short, concise, concrete terms.
Keep sentences short.
- Use as few words as possible. Only include directions for performing the job.
Do not include information on such things as the logic behind the job
responsibility.
- Highlight critical words by italicizing, underlining, or typing in all capital
letters. Always highlight the word "not."
Designand producethe job aid.
Testthe effectiveness and accuracy of the job aid.
Maintain current and highly effective job aids.

PREPARE THE TRAINEE
Check levelof interest.
Grab interest, focusedon the subject.
Establishwhy learn this.
Let trainee(s)know what to look for.
Use the WHOLE - PARTS - WHOLE approachto provide an overview of
what is expected. This helps focus on what is to be learnedbefore getting into
details.

PRESENT THE TRAINING
Show, tell and instruct the trainee concerning the job responsibility.
Use terms that are specific.
Use training aids when appropriate.
Provide repeatedpractice at eachstep requiring proficiency and skill.
Achieve competence through questions:
- Ask trainee to explain what has just been done.
- Ask trainee to identify deviations from presented techniques.
- Ask how presentedtechniques could have avoided a problem.
- Ask what, when and why things are going correctly.
Use side-by-side technique for demonstrations.
Introduce exceptions only after normal procedure is "lockedin."

REINFORCE TRAINING
Make sure that trainee knows where and when to ask for help.
Require performance of whole process on-the-job.
Ask for explanations during performance.
- what are you doing?
- how are you doing it?
- why are you doing it that way?
- how would you handle keyexceptions on-the-job?
Provide constructive and productive feedback.
Encourage peerfeedback during performance.
Encourage self-developmentand self-management.

PRACTICE: PREPARE, PRESENT & REINFORCE
Instructions: Record observations during example for each stepyou observe. Be prepared
to share with group during discussion.
PREPARE THE TRAINEE
_____ Put trainee at ease by encouraging talk about present skill level.
_____ Reduce fear by expressing confidence in trainees ability.
_____ Orient trainee to the work area and job duties.
_____ Explain the importance of the job or task.
_____ Show trainee the personal benefits of good job performance.
PRESENT
_____ Show and explain each step in a logical and systematic way.
_____ Use side-by-side technique to avoid teaching in reverse.
_____ Emphasize key points by explaining the reasons and importance.
_____ Use terms that are familiar and be consistent.
_____ Ask questions to determine understanding.
_____ Have trainee demonstrate the task.
_____ Have trainee explain the task.
_____ Correct any errors immediately.
_____ Use training aids.
REINFORCE AND FOLLOW-UP
_____ Make sure trainee knows where and when to ask for help.
_____ Observe trainee on-the-job.
_____ Give positive feedback throughout instruction for things done well.

THE COMPLEMENTARY CRITIQUE
What - Providing feedback on the work of another
Why - To achieve exemplary performance
To build on strengths
To identify weaknesses for improvement
How - Select feedback type
Direct - between feedback coach/observer and performer
Immediate - to protect relevance
Certain - performer is informed of the process
Assign responsibilities
Performer
Feedback coach
Observers/Peers
Critique performance
Maintain self-esteem and self-respect
Document specific observations - Time/Observations/Comment
Objective comments
Balanced feedback
- strengths
- weaknesses
Conduct the Critique
Order of Critique
-Performer/Feedback coach/Observer
Ask performer
-how do you feel?
-What would you change?
Provide feedback- Feedback Coach/Observer
-Specific and sincere
-Tell if a basic idea is not used or is misused
-Focus on process not content
-Make important points relative to effectiveness and efficiency
-Limit to points where corrective action can be taken
-Provide useful and practical way to improve skill on the job
Summarize strengths and weaknesses
-Agree on Actions and follow-up

GIVING BEHAVIORAL FEEDBACK
PURPOSE:To clearly, correctlyand conciselycommunicate the observed
behavior in a manner that the information will be acceptedand used.
HOW: Document FactualInformation.
Be Specific -Describe what the trainer actually said or did, the
circumstances, andthe trainees verbal and nonverbal responses
and the time of the observation.
Provide BehavioralDescriptions oftraining actions and reactions to
those actions.
- "When you askedthe trainee..., I felt he might have had a hard
time understanding what you wanted."
- "I know the trainee must have been pleasedabout your
comment regarding... I know I would have been.

STEPS TO DELIVER ON-THE-JOB TRAINING
Prepare the learner
Presentthe information
Reinforce and follow-up

ASSESS THE TRAINEE'S STAGE OF LEARNING
FOUR STAGES OF LEARNING
STAGE 1 - UnconsciouslyIncompetent
STAGE 2 - ConsciouslyIncompetent
STAGE 3 - ConsciouslyCompetent
STAGE 4 - UnconsciouslyCompetent

MANAGE THE TRAINEE'S STAGE OF LEARNING
TRAINEE
UnconsciouslyIncompetent
ConsciouslyIncompetent
ConsciouslyCompetent
UnconsciouslyCompetent
TRAINER

APPLICATION: OJT PRACTICE TRAINING
Purpose:Practice for OJT Trainers, Trainees and Observers.
Practice using Systematic Teaching.
Apply Adult Learning Principles.
Obtain feedback and suggestions forimprovement.
Practice using the Complementary Critique.
Build training and assessing ability.
Build confidence in training and assessing ability.
Increase insight into On-the Job training process.
Practice and observe various behavior and styles of OJT
PRACTICE
Prepare to teachsomeone to serve as your temporary back-up in the event of
your absence from work.

GUIDELINES FOR RESPONDING TO FEEDBACK
LISTEN AND TAKE BRIEF NOTES
ASK FOR MORE INFORMATION WHEN NEEDED
ASK FOR SPECIFIC BEHAVIORAL DESCRIPTIONS
RESTATE FEEDBACKTO ENSURE UNDERSTANDING
ALWAYS THANK THE FEEDBACKCOACH

KEY FEEDBACK AREAS TO OJT TRAINERS
TRAINING ATMOSPHERE
TRAINER'S BODYLANGUAGUE
- MANNER (STIFF, FORMAL, RELAXED)
- POSTURE
- BODY MOVEMENTS
- TIME
- INTEREST
- EYE CONTACT
TRAINER'S COMMUNICATION STYLE
- CLEAR, CONCISE,CORRECT
- DIRECTED TO THE TRAINEE'S LEARNING STAGE
- CONCERNFOR UNDERSTANDINGBYTRAINEE
TRAINER'S STYLE AND USE OF OJT TECHNIQUES
- PREPARED AND WELL-ORGANIZED TRAINING PLAN
- LOGICAL AND SYSTEMATIC SEQUENCING
- APPRORIATE USE OF TRAINING AIDS
- APPROPRIATE USE OF MEDIA
- PREPARED THE TRAINEE/CHECKEDLEARNING LEVEL
- EFFECTIVE REINFORCEMENT OF TRAINING
- EFFECTIVE WHOLE - PARTS - WHOLE PRESENTATION
- MAINTAINED SELF ESTEEMOF TRAINEE
- AMPLE OPPORTUNITIES TO PRACTICE
- EFFECTIVE SIDE-BY-SIDETRAINING TECHNIQUE

NEXT STEPS
ISSUES
ACTIONS
RESPONSIBILITIES
RESOURCES
DATES
Technical Trainer SPECIFIC OBJECTIVES
MITCH
1. CUSTOMER SURVEY 12/31 50 POINTS
2. TRIAD 12/31 20 POINTS
3. CURRICULA 12/31 10 POINTS
4. DEPT INDICATORS 12/31 100 POINTS
ERNEST
BPCS 40 POINTS
TONY
JAMES
PMD TRAINING TASK FORCE 20 POINTS

MICHAEL
JERRY
4. SITE CGMP TRAINING 12/31 10 POINTS
5. RECYCLING TRAINING/12/31 10 POINTS
6. TO BE ASSIGNED 12/31/95 10 POINTS
7. DEPT INDICATORS 12/31/95 60 POINTS
JEAN
SPF UTILITIES INSPECTION 20 POINTS
SPF PRE-APPROVAL INSPECTION 20 POINTS
FRANK
TTSNWT TRAINING ACTION Fiscal Year
MANNING, MITCH EIN O3624
1. TRIAD II 11/xx
2. 2-6010-0036 11/xx
3. 2-6010-0046 11/xx
4. TTS CURRIC REQMNTS 12/xx
ERNEST
1. TRIAD II 11/xx
2. 2-6010-0036 11/xx
3. 2-6010-0046 11/xx
5. LEADERSHIP ASSMNT 12/xx

TONI
1 - 4 PLUS
5. TARGETED SELECTION 12/xx
JIM
1 - 5 PLUS
6. NEW PMD EQUIPMENT TRAINING 12/xx
7. BULK PHARMACEUTICAL CHEMICAL PROCESS VALIDATON 12/xx
MIKE
1 - 5
JERRY
1 - 5 PLUS
6. NEW EQUIPMENTPROCESS TRAINING 12/xx
7. TARGETED SELECTION 12/xx
8. FDA INTERACTIONS 12/xx
9. KEPNER TREGOE PS/DM 12/xx
JEAN
1 - 5 PLUS
6. TARGETED SELECTION 12/95
FRANK
1. TRIAD II 11/xx
2. 2-6010-0036 11/xx
3. 2-6010-0046 11/xx
5. LEADERSHIP ASSMNT12/95
From: Mitchell W. Manning To: P&E Executive Committee
Date: November 1, xx
Subject: Technical Training Customer Survey for Fiscal Year Tasks and Projects
The following information will be presented and discussed at the P&E Staff meeting on
November 7. This is to inform you of the Customer Survey, the Technical Trainer assignments
by area, the survey approach, the survey results, the recommendations and the proposed action
plan to address the identified tasks and projects. Call Mitch Manning at extention 72810 if you
have questions, or recommendations, that you want to discuss before the meeting.
CUSTOMER SURVEY OVERVIEW
Survey Objectives:

Identify specific customer training tasks and projects by area.
Document the diversity of requests across P&E Unit.
Group training requests into major categories.
Estimate resource requirements to complete identified tasks and projects.
Contrast resource requirements with available resources.
Initiate action planning by area to prioritize tasks and projects.
Survey Background and Approach:
The Technical Training Specialists - Natural Work Team conducted area customer surveys between July
13, xx and September 7, xx. They collected information from one-on-one meetings and correspondence
in assigned areas. They asked "how do you want my time spent in Fiscal Year?" The responses were
compiled into lists of tasks, projects and responsibilities by TTS/Division. Start dates and completion
dates were identified when provided by management. (Note: The TTSs have continued to review and
refine the compiled information with their assigned line management and Division Managers.)
TTS Assignments by Area:
Area TTS
Engineering Division Mike
Logistics Administration Frank
Pharmaceutical Production Services, Small Scale Formulations Jerry
and Ointments, Creams & Liquids Formulations Divisions
Primary Manufacturing Division Jim
Solid Dose Formulation Division (Packaging and Manufacturing) Ernest
SPF & Manufacturing Documentation Control & Validation Division Jean
Sterile Products Division Frank
Greenville Site Mitch
RESULTS OF THE CUSTOMER SURVEY:
A high number of diverse training tasks, projects and responsibilities were identified.
The following major categories were identified:
1. Compliance Training
2. TRIAD
3. Curricula for Active Job Codes
4. Training Plans
5. Training Programs
6. Training Support
7. Performance Audit
8. Work Place Learning Center and General Education Improvement Program (WPLC/GEIP)
Note: See attached chart (DIVERSITY OF CUSTOMER REQUESTS FOR TTS-NWT TASKS
AND PROJECTS BY CUSTOMER AREA)

The POTENTIAL CAPACITY REQUIREMENTS PER MAJOR TRAINING CATEGORY (hours
required annually) were calculated. Requirements exceedTTS capacity.
Note: See attached charts for POTENTIAL CAPACITY REQUIREMENTS and KEY STATISTICS
FOR TTS-NWT CAPACITY REQUIREMENTS PLANNING.
Other Results of the Customer Survey:
Key issues around roles, responsibilities and customer expectations were identified.
1. Some line managers believe the TTS is responsible for job related employee qualifications.
2. Some line managers believe that the TTS is responsible and accountable for all SOP
training and documentation.
The understanding of technical and regulatory training compliance needs was enhanced.
1. CFR 211.25 - Personnel Qualifications was reviewed and discussed.
2. SOPs 2-6010-0036 - Technical Training and Qualification and 2-6010-0046 - TRIAD were
reviewed and discussed.
Note: These SOPS have been rewritten and approved for site-wide application by Ranthi Dev,
Joyce Aydlett, Dr. John Bettis and Dr. Craig Williams. Mandatory training for line management
will be completed by December 12, 1994.
The customers indicated an enhanced appreciation for the TTS direction and support for regulatory
training compliance.
Customers and TTSs have indicated that they think the survey was value-added.
RECOMMENDATIONS:
Establish a Training Task Force in each area to do the following:
1. Review the Customer Survey to identify opportunities for merging and piggybacking tasks,
projects and responsibilities (eg. Production Technician Training, Packaging Area Technician
Training, Chemical Process Operator Training, Multiskill and SPF Core Curriculum).
2. Review the survey for opportunities to distribute the training workload (eg. SOP pending
training reports to area clerical/secretarial designees)
3. Determine priority, or necessity, and resource requirements of each task, project and
responsibility with regulatory compliance as priority one.
4. Establish agreement on priorities based on resource requirements and contribution to
function.
5. Identify source and allocation of people (time), money, and other required resources.
6. Establish goals, measurement and schedule for each task, project and responsibility.
7. Develop, approve, implement and track Area Specific Training Action Plans.
Submit Requests for Service to Site Training and Development for each required task, project and
responsibility.

Establish minimum compliance training as the highest priority (mandatory without exception).
Develop and maintain curricula for each active job code and use to provide operational control of
minimum compliance training for each employee.
Monitor and manage minimum compliance training utilizing printed reports from Training Database
Administration:
1. First-line supervisor Monthly
2. Middle manager Quarterly
3. Senior manager Interim and Annual
4. Executive manager Annual
Appoint SOP Designees at clerical/secretarial level to provide administrative support (monitor New
and Revised SOPs, prompt required SOP training, prepare and distribute training materials, collect
completed Training Attendance Documents, review with instructor for accuracy and completeness
and ensure timely delivery to Training Database Administration, eg. SDFD pilot program).
Concentrate Technical Training Specialist assignments on approved Requests For Service for new,
or changed, equipment, procedures and regulations within assigned area with expressed approval of
the area Division Manager.
PROPOSED ACTION PLAN:
TTS to review survey with Division Manager or designee(s) November 30, xx
Division Manager or designee establishes Training Task Force November 30, xx
Training Task Force establishes Training Action Plan December 31, xx
Division Managers monitor progress against the plans On-going
pemgtprs.doc
TECHNICAL TRAINING HOURS REQUIRED FOR Fiscal Year
TASKS/PROJECTS BPCS ENG LOG PPS/SSF
/OCL
PMD SDFMD SPD SPF SITE
Regulatory Compliance 0 1380 375 1044 175 200 575 2020 0416/
Technical Training 1200 1420 0 1040 800 180 1312 400 0416/
Other 1200 735 120 200 595 60 0 256 0832/
REQUIRED HOURS 2400 3535 495 2284 1570 440 1887 2676 1664/
TTS-NWT HOURS 1664 1704 495 1704 1664 440 1169 1744 1664/
HOURS NEEDED 736 1831 0 580 +94 0 718 932 0000/

TTS-NWT Member Clemons Langley Taylor McRoy Hodges Allen Taylor Mitchell Mann
CALCULATIONS:
REQUIRED HOURS: Regulatory Compliance + Technical Training + Other
TTS NWT HOURS: 52wks x 40hrs - (vacation + holidays(88) + training(24) + meetings(40) + sick time(24)
performance management(40))
HOURS NEEDED: Required Hours - TTS NWT Hours
PROJECTS/TASKS PRIMARY CONTACT:
 BPCS - Ernest
 Engineering - Mike
 Logistics - Frank
 Pharmaceutical Production Support, Small Scale Formulations, and Ointments, Creams and
Liquids Formulations - Jerry
 Primary Manufacturing Division - Jim
 Solid Dosage Formulations Division - Lou (assigned from ST&D staff)
 Sterile Products Division - Frank
 Sterile Products Facility - Jean
 Site - Mitch
Training Database Administration - Toni
Site-Wide Technical Training Projects - Michelle (assigned from ST&D staff)
Work Place Learning Center - Joyce (Pitt Community College)

.
KEY STATISTICS FOR TTS-NWT CAPACITY REQUIREMENTS
PLANNING
FACTORS ENG LOG PPS/SSF/OCL PMD SDFD SPD SPF
Number of Employees 408 154 165 176 193 093 163
Operative/Craft 217 066 140 121 168 074 015
Prof/Tech/Admin 125 088 007 023 006 024 122
Supervisors 042 016 012 015 014 009 015
Department Heads 015 003 004 005 003 002 007
Managers 006 005 000 001 000 000 002
Directors 002 000 002 001 001 001 000
Vice Presidents 001 001 000 000 001 000 001
Active Job Codes 231 087 048 042 25 041 047
Procedures 206 152 201 240 210 147 065 aprv
TTS-NWT Member Langley Taylor McRoy Hodges Allen Taylor Mitchell
Note: Employee numbers include temporary employees.
Calculations BasedOn Past Performance:
Compliance Training: 2 hours for each procedure
Curricula: 4 hours for each active Job Code
Training Plans: 1 hour for each employee
TRIAD: 1 hour for each employee
**Training Programs: 400 hours to design, develop and implement/ 100 hours to customize and implement (f
each program)
**Training Support: 400 hours to design, develop and implement/ 100 hours to customize and implement (for
each type support)
Performance Audit: 1 hour for each employee
WPLC/GEIP: 2 hours for each enrolled employee (2% of employee pool)
Estimates are based on experience, past performance and guidelines
From: Mitchell W. Manning To: Craig & Jim E
Date: February 13, XXXX
Subject: Technical Training Action Plans for YEAR
The technical training action plans (by area) are attached. Each plan has been reviewed by the
area division manager and/or designee(s). Significant progress has been made in all areas since I
presented the results of the Technical Training Customer Survey to the P&E Executive
Committee on December 2, XXXX. The progress is recorded in bold on the attached copies of
the original presentation documents. Please review the action plans and the progress reports. I
would like to meet with you on Tuesday or Wednesday (2/14 or 2/15) to review the plans and to
discuss our next steps.

attachments:
Area Action Plans
Mike - Engineering
Frank - Logistics and Sterile Products Division
Jim - Primary Manufacturing Division
Jerry - Ointments, Creams and Liquids Formulations, and Pharmaceutical
Production Support & Small Scale Formulations
Lou - Solid Dosage Formulations & Manufacturing Division
Jean - Sterile Products Facility
Status Report on the Original Presentation
mm/stored on C:aplnmemo.doc

STATUS REPORT: 2/13/XXXX (see Recommendations andProposedAction Planforprogress)
TTS-NWT TASKS AND PROJECTS FOR YEAR BY CUSTOMER
Presented to the P&E Executive Committee on November 7, XXXX (actual 12/02/XXXX)
By Mitch Manning, Section Head Technical Training SITE TRAINING & DEVELOPMENT
Survey Objectives:
13, XXXX and September 7, XXXX. They collected information from one-on-one meetings and
correspondence in assigned areas. They asked "how do you want my time spent in XXXX?" The
responses were compiled into lists of tasks, projects and responsibilities by TTS/Division. Start dates
and completion dates were identified when provided by management. (Note: The TTSs have continued
to review and refine the compiled information with their assigned line management and Division
Managers.)
Area TTS
Site Mitch Manning
Note: updated on 2/13/95, mm/ stored on c:aplnmemo.doc

From: Mitchell W. Manning To: P&E Executive Committee
Date: November 1, XXXX
Subject: Technical Training Customer Survey for XXXX Tasks and Projects
The following information will be presented and discussed at the P&E Staff meeting on
November 7. This is to inform you of the Customer Survey, the Technical Trainer assignments
by area, the survey approach, the survey results, the recommendations and the proposed action
plan to address the identified tasks and projects. Call Mitch Manning at extention 72810 if you
have questions, or recommendations, that you want to discuss before the meeting.
Survey Objectives:
13, and September 7, XXXX. They collected information from one-on-one meetings and
correspondence in assigned areas. They asked "how do you want my time spent in xxxx?" The responses
were compiled into lists of tasks, projects and responsibilities by TTS/Division. Start dates and
completion dates were identified when provided by management. (Note: The TTSs have continued to
review and refine the compiled information with their assigned line management and Division
Managers.)
Area TTS

RESULTS OF THE CUSTOMER SURVEY:
A high number of diverse training tasks, projects and responsibilities were identified.
The following major categories were identified:
1. Compliance Training
2. TRIAD
3. Curricula for Active Job Codes
4. Training Plans
5. Training Programs
6. Training Support
7. Performance Audit
8. Work Place Learning Center and General Education Improvement Program (WPLC/GEIP)
Note: See attached chart (DIVERSITY OF CUSTOMER REQUESTS FOR TTS-NWT TASKS
AND PROJECTS BY CUSTOMER AREA)
The POTENTIAL CAPACITY REQUIREMENTS PER MAJOR TRAINING CATEGORY (hours
required annually) were calculated. Requirements exceedTTS capacity.
Note: See attached charts for POTENTIAL CAPACITY REQUIREMENTS and KEY STATISTICS
FOR TTS-NWT CAPACITY REQUIREMENTS PLANNING.
Other Results of the Customer Survey:
Key issues around roles, responsibilities and customer expectations were identified.
1. Some line managers believe the TTS is responsible for job related employee qualifications.
2. Some line managers believe that the TTS is responsible and accountable for all SOP
training and documentation.
The understanding of technical and regulatory training compliance needs was enhanced.
1. CFR 211.25 - Personnel Qualifications was reviewed and discussed.
2. SOPs 2-6010-0036 - Technical Training and Qualification and 2-6010-0046 - TRIAD were
reviewed and discussed.
Note: These SOPS have been rewritten and approved for site-wide application by Senior
Management. Mandatory training for line management will be completed by December 12, xxxx.
The customers indicated an enhanced appreciation for the TTS direction and support for regulatory
training compliance.
Customers and TTSs have indicated that they think the survey was value-added.
RECOMMENDATIONS:
Establish a Training Task Force in each area to do the following:

1. Review the Customer Survey to identify opportunities for merging and piggybacking tasks,
projects and responsibilities (eg. Production Technician Training, Packaging Area Technician
Training, Chemical Process Operator Training, Multiskill and SPF Core Curriculum).
2. Review the survey for opportunities to distribute the training workload (eg. SOP pending
training reports to area clerical/secretarial designees)
3. Determine priority, or necessity, and resource requirements of each task, project and
responsibility with regulatory compliance as priority one.
4. Establish agreement on priorities based on resource requirements and contribution to
function.
5. Identify source and allocation of people (time), money, and other required resources.
6. Establish goals, measurement and schedule for each task, project and responsibility.
7. Develop, approve, implement and track Area Specific Training Action Plans.
Progress: It was not deemed necessary to form Task Forces. The review and planning was handled
by ST&D and line management in each area. 1. The survey was reviewed to merge and piggyback
projects.
2. The workload was distributed within ST&D and in the area. All areas are using SOP designees.
3. Priorities have been established per the attached Action Plans. 4. Same as #3. 5. Resource
management will be on-going. 6. Target dates were set. Other goals and measurements need
additional work. 7. Action Plans are attached.
Submit Requests for Service to Site Training and Development for each required task, project and
responsibility.
Progress: All areas are submitting RFSs for training needs not identified in the Action Plans.
Establish minimum compliance training as the highest priority (mandatory without exception).
Progress: Compliance training is the highest priority in each area.
Develop and maintain curricula for each active job code and use to provide operational control of
minimum compliance training for each employee.
Progress: More than 250 curricula have been compiled and entered into TRIAD for the operative
and craft positions. More than 200 professional/technical/management curricula have been
completed.
Monitor and manage minimum compliance training utilizing printed reports from Training Database
Administration:
1. First-line supervisor Monthly
2. Middle manager Quarterly
3. Senior manager Interim and Annual
4. Executive manager Annual
Progress: TRIAD training in all areas has enabled management/supervision to track training on
an on-going basis.
Appoint SOP Designees at clerical/secretarial level to provide administrative support (monitor New
and Revised SOPs, prompt required SOP training, prepare and distribute training materials, collect

completed Training Attendance Documents, review with instructor for accuracy and completeness
and ensure timely delivery to Training Database Administration, eg. SDFD pilot program).
Progress: SOP designees have been appointed and trained in all areas. There have been no
complaints with the work that they have performed.
Concentrate Technical Training Specialist assignments on approved Requests For Service for new,
or changed, equipment, procedures and regulations within assigned area with expressed approval of
the area Division Manager.
Progress: The Technical Training Specialist and ST&D staff assignments have become more
focused on technical training assignments through RFSs.
PROPOSED ACTION PLAN:
TTS to review survey with Division Manager or designee(s) November 30, xxxx
Progress: Completed. See attached Action Plans. Changed to 12/23/xx
Division Manager or designee establishes Training Task Force November 30, xx
Progress: Completed without establishing Task Force(s). Changed to 12/23/xx
Training Task Force establishes Training Action Plan December 31, xx
Progress: Completed without establishing Task Force(s) Changed to 1/31/xx
Division Managers monitor progress against the plans On-going
Progress: Ongoing
TECHNICAL TRAINING SPECIALIST P&E UNIT - MASTER TRAINING PLAN
REQUIRED TRAINING FORM FOR CFR 211.25 PERSONNEL QUALIFICATIONS
Job Description(title): Error! Reference source not found.
Employee/EIN: Error! Reference source not found. Department/cc: Error! Reference
source not found.
Supervisor/EIN: Error! Reference source not found. Training Period: Error! Reference
source not found.
INSTRUCTIONS: This form is designed to assist the Supervisor in developing a technical
training and qualification plan to support employee qualification for the essential duties
identified in the applicable Job Description. Required training is defined as training which targets
job specific orientation, regulatory compliance(eg CGMPs, OSHA, EPA, DOL, DOT, AF&T,
etc.), procedures (SOPs, GAPs, SPBs, etc) equipment, process, and technology. Record internal
and external courses and programs on this form. ST&D staff are available to assist upon request.
TRAINING AND QUALIFICATION ACTION PLAN) Target Date Frequency

Identification Number/Title or Description Start/Complete Update
1. ORIENTATION
2. REGULATORY COMPLIANCE (list all MANDATORY procedural training)
3. PROCEDURES (list any non regulatory compliance procedural training)
4. EQUIPMENT
5. PROCESS
6. TECHNOLOGY
7. OTHER
SIGNATURES: Employee
_______________________________ Date:
_______________________
Supervisor_______________________________ Date:
_______________________
Send a signed and dated copy of the completed form and a copy of the working Job Description (may be pending
approval by line management, Human Resources and Compensation) to the Section Head - Technical Training.
Give the employee a signed and dated copy of the completed form to encourage self-development and self-
management of the Training and Qualification Plan.
The Huge Curve Ball
February 2, xxxx
Mr. Robert xxxxxx
Major Vendor Corporation
Address Hidden
Dear Bob:
Thanks for providing the references on mergers and acquisitions. I had no idea when we talked
that Wellcome Plc was about to be acquired. It looks as if we will soon be Glaxo Wellcome Plc.
The books will be useful in understanding the process. Hopefully, I will be able to enhance my

effectiveness during the transition as a result of the information you have provided. Thanks very
much.
Sincerely,
Mitch Manning
Section Head, Technical and Regulatory Compliance Training
ps Are you familiar with the work and writing of Dr. Kathryn Harrigan of Columbia
University? I heard her speak on M&A implementation strategies a couple of years ago.
Training Tasks and Projects after the Curve Ball
From: Mitchell W. Manning To: VP Production and Eng. and Staff
Date: October 5, xxxx
Subject: TTS-NWT Tasks and Projects for xxxx
(Note: This information is provided in advance for the P&E Staff meeting scheduled on October 11.)
The Technical Training Specialists - Natural Work Team conducted a customer survey between
July 13, xxxx and September 7, xxxx. The objective was to identify what the area line
management wants the assigned Technical Training Specialist to do in 1995. The full report was
submitted to Mr. VP for review on September 9. This is to inform you of the Customer Survey,
the Technical Trainer assignments by area, the findings, the recommendations and the action
plan to address the identified tasks and projects.
TTS Assignments
Area TTS
Engineering Division (GVL & RTP) Mike
and Ointments, Creams & Liquids Division
Approach:
The TTS-NWT collected information from one-on-one meetings and correspondence in assigned
areas. They asked "how do you want my time spent in xxxx?" The responses were compiled into
lists of tasks, projects and responsibilities by TTS/Division. Start dates and completion dates
were identified when provided by management. (Note: The TTSs will review the compiled
information with their assigned Division Manager.)

Results:
A high number of training tasks, projects and responsibilities were identified.
The identified tasks, projects and responsibilities fall into the following major categories:
Auditing Regulatory Compliance Training
Design and Delivery of New or Modified Procedure Training
Design and Delivery of New or Modified Equipment Training
Administrative Support for Training Curricula and Training Plans
More in-depth thinking on technical and regulatory training compliance needs was initiated.
Issues around roles, responsibilities and customer expectations were identified.
The customer response to the survey was positive.
The customer expectations of the TTS were adjusted.
Recommendations:
Empower a Training Task Force in each area to do the following:
Review the lists to identify opportunities for merging and piggybacking (eg. Production Technician
Training, Packaging Area Technician Training, Chemical Process Operator Training and Multiskill).
Review the list for opportunities to distribute the training workload (eg. SOP pending training
reports to area clerical/secretarial designees)
Determine priority, or necessity, and resource requirements of each task, project and responsibility
with regulatory compliance as priority one.
Establish agreement on priorities based on resource requirements and contribution to function.
Identify source and allocation of each resource.
Establish goals, measurement and schedule for each task, project and responsibility.
Develop, approve, implement and track Area Specific Training Action Plans.
Proposed Action Plan:
TTS to review list with Division Manager or designee(s) October 31, xxxx
Division Manager or designee(s) establishes Training Task Force October 31, xxxx
Training Task Force establishes Training Action Plan December 31, xxxx
Division Manager monitors progress against the plan On-going
tkspjts95
pemgtprs.doc
DIVERSITY OF CUSTOMER REQUESTS FOR TTS-NWT TASKS AND PROJECTS BY CUSTOMER
AREA
TASKS/PROJECTS ENG LOG PPS/SSF/OCL PMD SDFD SPD SPF S

Compliance Training yes yes yes yes yes yes yes y
SOPs, SOMS, etc. yes yes yes yes yes yes yes y
FDA/CGMP yes yes yes yes yes yes yes y
OSHA yes yes yes yes yes yes yes y
EPA yes yes yes yes yes yes yes y
Other yes yes yes y
TRIAD yes yes yes yes yes yes 2-
Curricula yes yes yes yes yes yes 2-
Training Plans yes yes yes yes yes yes 2-
Training Programs
Equipment O&M yes yes yes yes yes yes y
Basic Computer yes yes yes
Advanced Computer yes yes yes yes y
One-of-a-Kind 8 4 9 19 10 5
New Employee yes yes yes yes y
NWT yes yes yes
Skill Upgrades yes yes yes yes R
Pre-employment yes yes yes y
Supervisor yes
Training Support
Computer Based yes yes yes yes yes y
Classroom yes yes yes y
Multimedia yes yes y
Laser Disc yes y
Outside/Vendor yes yes yes y
Manuals yes 6 y
Performance Audit yes yes yes y
WPLC/GEIP yes yes y
TTS-NWT Member Langley Taylor* McRoy Hodges Clemons* Taylor* Mitchell M
POTENTIAL CAPACITY REQUIREMENTS PER MAJOR TRAINING CATEGORY (hours required annually)
TASKS/PROJECTS ENG LOG PPS/SSF/OCL PMD SDFD SPD SPF S
Compliance Training 412 304 402 480 420 394 130 N
TRIAD 408 154 165 176 193 93 163 1
Curricula 924 348 192 168 100 164 188 N
Training Plans 408 154 165 176 193 93 163 1
Training Programs** 4400/1100 3200/800 6400/1600 10400/2600 5200/1300 400/100 3200/800 N
Training Support** 1600/400 0 1600/400 1600/400 2800/700 000 1200/300 N
Performance Audit 000 154 000 176 000 000 163 1
WPLC/GEIP 018 006 006 008 008 004 006 N
TTS-NWT Member Langley Taylor* McRoy Hodges Clemons* Taylor* Mitchell M
*Frank is assigned to Logistics, Sterile Products Division and is TRIAD Project Leader.

*Ernest has been assigned full-time to BPCS.
*Joyce is the Pitt Community College instructor for the Work Place Learning Center/General Education Improvement Program
Calculations Based On Past Performance:
Compliance Training: 2 hours for each procedure
TRIAD: 1 hour for each employee
Curricula: 4 hours for each active Job Code
Training Plans: 1 hour for each employee
**Training Programs: 400 hours to design,develop and implement/ 100 hours to customize and implement (for each program)
**Training Support: 400 hours to design,develop and implement/ 100 hours to customize and implement (for each type support)
Performance Audit: 1 hour for each employee
WPLC/GEIP: 2 hours for each enrolled employee (2% of employee pool)
**High/Low estimates are provided to establish a range for hours required. Estimates are based on experience and guidelines.

KEY STATISTICS FOR TTS-NWT CAPACITY REQUIREMENTS PLANNING
FACTORS ENG LOG PPS/SSF/OCL PMD SDFD SPD SPF
Number of Employees 408 154 165 176 193 093 163
Operative/Craft 217 066 140 121 168 074 015
Prof/Tech/Admin 125 088 007 023 006 024 122
Supervisors 042 016 012 015 014 009 015
Department Heads 015 003 004 005 003 002 007
Managers 006 005 000 001 000 000 002
Directors 002 000 002 001 001 001 000
Vice Presidents 001 001 000 000 001 000 001
Active Job Codes 231 087 048 042 25 041 047
Procedures 206 152 201 240 210 147 065 aprvd
TTS-NWT CAPACITY 1704 1664 1704 1664 000 000 1744
PT. CAPACITY REQ** 8170/3670 4320/1920 8930/2930 13184/4184 8914/2914 1148/848 5213/1750
CAPACITY DEFICIT** 6466/1966 2656/256 7226/1226 11520/2520 8914/2914 1148/848 3469/006
TTS-NWT Member Michael Frank Jerry Jim Ernest Frank Jeanl
*Frank is assigned to Logistics, Sterile Products Division and is TRIAD Project Leader.
*Ernest has been assigned full-time to BPCS (1664 hours).
*Joyce is the Pitt Community College instructorfor the Work Place Learning Center/General Education Improvement Program
Note: Employee numbers include temporary employees.
Calculations:
TTS-NWT Capacity: 52wks times 40hrs minus (vacation + holidays + training + meetings + sick time + performance managemen
(vacation + holidays(88) + training(24) + meetings(40) + sick time(24) + performance management(40))
Potential Capacity Requirements: Total from Potential Capacity Requirements chart
Capacity Deficit: Potential Capacity Requirements minus TTS-NWT Capacity
**High/Low estimates are provided to establish a range for hours required. Estimates are based on experience and guidelines.
MEMORANDUM
Burroughs
Wellcome
Co.
SITE TRAINING AND
DEVELOPMENT
FROM: Mitch Manning TO: Craig and Sheila
CC: Michelle
DATE: 02/15/xxxx
SUBJECT: Technical Training Assignments for Michelle
Please consider assigning the technical training responsibilities listed below to Michelle. The
responsibilities are listed in priority order. Michelle and I have discussed the responsibilities and
believe that she can do an excellent job with them. I accept full responsibility for performance

management and evaluation relative to the final assignments. A prompt response is requested due
to the immediacy of the responsibilities.
1. Curricula development and implementation for all P&E job codes not assigned to Technical
Training Specialists.
- Identify cost centers/job codes not covered
- Conduct curriculum development interviews with appropriate line management
- Enter curricula into TRIAD
- Prompt and track related training plans
Estimated Time Required: 600 hours Targeted Completion: 12/31/xxxx
2. Staff liason/coordinator for the Work Place Learning Center.
- Interface with Pitt Community College instructor/counselor
- Research and develop "best practices" job-related WPLC services
- Interface with testing function in Human Resources
- Design, develop and implement value-added WPLC services
- Provide direction and support for customers (all areas and levels) of WPLC
3. TRIAD audits and management reports (if requested.)
- Randomly audit TRIAD and support records for accuracy and timeliness
- Develop customer reliance and expertise on TRIAD management tools
- Prepare and present executive summary reports quarterly
4. Multi-Media projects on Test Construction Set.
- Identify, design, develop and deliver core curriculum courses on TCS
1) BW Co. Products and Processes 2) EPA and Site

5. Re-approval of existing SPF curricula for Pre-approval Inspection.
- Establish plan with Jean and Mike
- Implement the plan
Estimated Time Required: 100 Hours Targeted Completion: 4/03/xxxx
6. Liason with Human Resources for updating Change in Employee Status (P&E Unit only).
- Interface for technical training specialists and HR on CES
- Resolve CES issues
- Inform technical training specialists
Estimated Time Required: 100 Hours Targeted Completion: 12/31/xxxx
PROJECTS/PRIORITIES FOR xxxx
TRAINING DATABASE ADMINISTRATION - Toni
Priority: TRIAD II SYSTEM ADMINISTRATION
ACTION RESPONSIBLE
Ensure the testing and training system environments are maintained and administered to meet the
needs of the systemusers. Toni l
Support TRIAD II systemdata and functionality so as to coordinate training relevant information and
provide systemcontrol and troubleshooting of systemoriented problems. Toni l
Control, limit, and manage access to the TRIAD II data entry system. Act as liaison between training
database operators.
Toni /Mitch Manning/PEIS
Provide PeopleSoft/TRIAD II systemtraining and systemtraining and access to the Reports and
Queries TRIAD II database via CICS logon.
Toni /TTS/PEIS
Estimated Time: 780 hours
Priority: TRIAD II DATABASE OPERATOR
ACTION RESPONSIBLE
Provide timely entry of training records into the TRIAD II systemand ensure accuracy of such records
for the P&E unit employees and employees from otherunits not covered by a database operator.
Toni
Return incorrect training documentation to originators and track returns of documentation back to the
Training Database office.
Toni
Maintain course information relevant to courses specific to the assigned area. Toni
Receive and enter curricula from each support area into TRIAD II system. TTS/Toni
Maintain curricula for each support area job code as changes are needed Toni /TTS
Provide up-to-date training reports as requested by area management, supervision,etc. Toni l
Estimated Time: 1,040 hours
Priority: MIGRATION STRATEGY TEAM
ACTION RESPONSIBLE
Facilitate TRIAD II Migration Strategy Team to develop systemenhancements,troubleshoot,and
maintain data control over system.
Toni
Set up and maintain meeting schedule for Migration Strategy Team and prompt members of meeting
schedule.
Toni
Keep MST updated on systemenhancements and problems. Toni
Work with systemprogrammers regarding systemenhancements. Toni /Migration
Team/Programmers

Priority: HARD COPY STORAGE & RETRIEVAL OF REGULATORYTRAINING
DOCUMENTATION
ACTION RESPONSIBLE
Provide storage of hard copy training documentation for regulatory compliance training in the event of
an inspection.
Toni
Maintain current files on SOPs/SOMs/GAPs/Validation Procedures/Equipment Training and external
training assigned to Cost Centers within the P/E Unit and other units not covered by an administrator. Toni
Be prepared to produce hardcopy regulatory compliance documentation for inspection upon request by
supervisors,QAT Teams, Management, and FDA within one hour of request. Toni
Archive out dated documentation according to Record Retention Schedules. Toni
Project: MAINTAIN CODE OF FEDERAL REGULATIONS BOOKLET
ACTION RESPONSIBLE
Maintain Code of Federal Regulations Booklet Parts 210 and 211. Keep up-to-date changes
incorporated into booklet for in-house publication.
Toni
Stock and distribute CFR Booklet for BWCo employees (site, RTP, UK, etc.). Toni
Project: MAINTENANCE OF TEST CONSTRUCTION - BWCO ELECTRONICTESTING
SYSTEM
ACTION RESPONSIBLE
Maintain registration to Test Construction Set. Toni
Enter employee data on to RosterMaker for test sign on. Toni
Run manual report daily to pass test data results to the TRIAD II system. Toni
Project: MULTIMEDIA CGMP TUTORIAL
ACTION RESPONSIBLE
Assist project team develop in-house MultiMedia CGMP ( Test Construction Software) using Parts
210 and 211 of the Code of Federal Regulations.
Toni /Project Team
Maintain information regarding CGMP MultiMedia tutorial via Test Construction Set. Toni
Register personnelto RosterMaker for the CGMP MultiMedia tutorial.
TECHNICAL TRAINING ACTION PLANS
FOR xxxx PROJECTS IN SDFMD
Project Request: Curricula development for all job positions in SDFMD
Estimated Hours Required: 200
ACTION RESPONSIBLE COMPLETE BY

Deliver sample curricula and SOP catalog to area supervisors Allen 1/15/xxxx
Receive approved curricula Allen 2/28/xx
Forward approved curricula for entry into TRIAD Allen
Harrell
3/15/xx
Project Request: Assist with developing and implementing Pharmaceutical Production
Technician Course
Develop training curriculum for new technicians Allen
Anderson
Angel
2/28/xx
Deliver initial technician training ST&D Staff
SMEs
Ongoing
Develop task lists/assessments as required by area management Allen
McRoy
8/31/xx
Assess training to determine the need for additional training. Allen
Supervision
9/29/xx
Project Request: Complete Korsch Training Manual
Complete Korsch Training Manual for SDFMD Compressing 3/15/xx

Project Request: Complete Training Manuals for Coating Rooms C&D
Estimated Required: 20
Complete training manuals for coating rooms C&D - SDFMD Coating 3/15/xx
Project Request: Complete Training Manual for D/3 System in Room M2-83
Complete training manual for D/3 System in Room M2-83 - SDFMD Granulating 3/15/xx
CONTENTS Table of Contents
Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE
Table of Contents . . . . . . . . . . . . . . . . . . . . . . CONTENTS
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .FIGURES
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0
Designated Individual . . . . . . . . . . . . . . . . . . . . . . 2.1
Training Frequency: C . . . . . . . . . . . . . . . . . . . . .3.0
List of SOP Cross References . . . . . . . . . . . . . . . . 4.0
List of Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . 5.0
Initial Distribution List . . . . . . . . . . . . . . . . . . . . . 6.0
FIGURES Figures
ID: 2-6010-0036 EFFECTIVE: 10/15/xx
PICTURE 1 SUPERSEDES NO. DATED: 09/19/xx

2-6010-0036
DEPARTMENT(S) IMPACTED: SITE
REVIEW CYCLE: 1 year REVISION CODE: 00
TITLE: Technical Training and Qualification Procedure for all P&E
Employees
Authored by: Approved by:
09/21/xx
ST&D Sec. Hd.
10/08/xx
Sr. V.P.
10/08/xx
Sect. Hd., QA
Issued by: Supv. SOP Oper. 10/08/xx
1.0 Purpose
The purpose of this procedure is to define the minimum training
requirements and to outline the duties, responsibilities and
accountability for providing training and administering the activities
necessary to maintain a skilled work force.

2.0 Procedure
The procedure is as follows:
I. SCOPE
This SOP will address only those activities associated with orienting
and training new employees in their job duties, qualifying employee
proficiency, meeting regulatory requirements and providing ongoing
training as may be necessary to maintain employee knowledge and skill
levels. Career development and advancement training, such as that
provided through apprenticeship programs, will not be covered by this
SOP.
II. GENERAL REQUIREMENTS AND RESPONSIBILITIES
2.1 Designated Individual
A. DIVISION MANAGER
As stated throughout this SOP, it is primarily the responsibility
of the Division Manager to ensure that the requirements of this
SOP are met. However, the specific action required to meet this
objective will be accomplished through the delegation of this
responsibility to Department Heads, Supervision, Technical
Training Specialists, and the Supervisor - Operative Technical
Training.
B. TECHNICAL TRAINING SPECIALIST
The role of the Technical Training Specialist is to coordinate the
development, implementation, and documentation of training
programs for the non-exempt production and engineering staff in
their respective division(s).
C. DEPARTMENTAL TRAINING PROCEDURES
Each division shall establish a divisional and/or departmental
technical training procedure that provides for proper
administration and documentation of training within their groups.
These procedures will be in compliance with the guidelines
provided in this document.
D. BUDGETS
ST&D will budget, based on division input, for operative technical
training and CGMP training. It shall be the responsibility of
each Division Manager to budget funds necessary to obtain training

programs, materials, audio visual aids, etc. as may be required
to provide the necessary job training for non-operative employees
within the division. In addition, where specialized training can
only be acquired by bringing in outside specialists or sending
employees out to vendor and supplier schools, it is the cost
center manager's responsibility to ensure that course
registration, travel and outside services funds are budgeted.
Programs for unit wide topics will be budgeted for and developed
by ST&D based on direction from the Training Steering Committee.
Programs for the Technical Lecture Series and Technical Training
Series will be funded by P&E Administration. The Training
Steering Committee and the High Technology Committee will approve
the topics for these programs.
E. BASIC JOB TRAINING CURRICULUM
Each Division Manager shall be responsible for insuring that a
training curriculum is established for each job classification
assigned to cost centers in his/her division. This curriculum
shall include division/department orientation, job training,
related technical instruction, safety instruction and CGMP
Regulations training requirements. All new employees shall be
required to complete all courses listed on their training
curriculum. In addition, all applicable SOP's for each job shall
be identified and included as part of the training curriculum
requirements for each job.
F. EMPLOYEE QUALIFICATION
It shall be the responsibility of the Division Manager to insure
that training requirements are established and maintained for each
position in his/her cost centers. The basic training requirements
for a new employee shall include:
1. Successful completion of appropriate curriculum courses.
2. Training on all SOP's related to the employee's job.
3. Successful demonstration of critical job skills.
G. ONGOING/REINFORCEMENT TRAINING
Division Managers shall be responsible for insuring that
appropriate reinforcement training is provided to their staff such

that required job knowledge and skills are properly maintained.
In addition, each Division Manager shall also be responsible for
insuring that training is provided on an ongoing basis as may be
necessary to comply with regulatory requirements and to meet the
changing job demands created by the introduction of new technology
and equipment. To meet this requirement, each division shall
establish an annual training plan for all employees in their area.
This plan shall provide for formal training for each employee in
addition to regular SOP training. The amount and type of training
required for each employee or position will be evaluated and
discussed during their performance review. From this, a training
plan for the next year will be developed.
H. TEMPORARY EMPLOYEE TRAINING PROCEDURES
It shall be the responsibility of each Division Manager that
utilizes outside temporary employees or employees temporarily
assigned from another division to insure that a temporary employee
training procedure is established and followed within their
department. This procedure shall include an outline or list of
training requirements and copies of training log sheets, forms,
etc. to be utilized in administering and documenting this
training.
I. COURSE ABSTRACTS
It shall be the responsibility of the Division Manager to insure
that course abstracts are prepared for each course or program
included in a job training curriculum. Site Training and
Development Department will provide assistance in developing
course abstracts.
J. RESPONSIBILITY FOR TRAINING ACTIVITIES
The supervisor of new employees shall be responsible for insuring
that a schedule of training is established and that each employee
completes the training prescribed in their training curriculum.
Supervisors, group leaders, OJT trainers, and/or the area
Technical Training Specialist shall be responsible for conducting
or providing the job training for employees, as may be required.

K. ANNUAL AUDIT OF TRAINING CURRICULUM
Once each year, all departments shall review and update the
training curriculum and job knowledge and skills tests for all
jobs in their area. This update should reflect changes that have
occurred in the job and also improvements made in courses or
programs used for training. The SOP training list for each job
should also be critically reviewed to insure that it reflects the
current requirements for each job.
L. COURSE CATALOG
It shall be the responsibility of the Site Training and
Development Department to publish and maintain a course catalog of
all technical training programs developed and used within the P/E
Unit.
III. DOCUMENTATION
A. RESPONSIBILITY FOR DOCUMENTATION
It shall be the responsibility of the employee's supervisor to
insure that all training required by this procedure is properly
documented and recorded within one calendar week of each training
event.
B. TRAINING CURRICULUM TRANSCRIPT
A training curriculum transcript, outlining job training
requirements for new employees, shall be prepared and a record of
the employee's training progress maintained in that document.
C. ATTENDANCE LOGS
An attendance log, sign-up sheet, or training curriculum record
shall be used to record attendance at all training sessions
conducted at BW Co. Each employee shall verify their attendance
and participation in the training activity by signing or
initialling the appropriate document.
D. VERIFICATION OF COMPLETION OF TRAINING
Each departmental training procedure shall provide for a periodic
review of training records to insure that all employees have
completed required training and that make-up sessions are
scheduled and conducted for those who may have missed a regularly

scheduled session.
E. OUTSIDE COURSES
Attendance at "outside" job related courses by an employee at the
request of BW Co. should be documented on the employee's training
record. In addition, certificates of completion, attendance, etc.
should be filed in the employee's personnel folder.
IV. REQUIRED TRAINING
Regulatory agencies such as the FDA, EPA, OSHA, etc. have mandated
through legislation and various guidelines that specific training be
required for employees involved in certain types of work. It shall be
the responsibility of the Division Manager to review the requirements
for each job category in their area and to establish the required
courses to be included on the training curricula for any of their
jobs. The Supervisor - Operative Technical Training will maintain a
list of required regulatory training.
V. STANDARD OPERATING PROCEDURE TRAINING
DOCUMENTATION OF SOP TRAINING
It shall be the responsibility of the first line supervisor to insure
that each employee is trained on all SOP's relevant to their job and
that the training has been properly documented. For more information
refer to SOP #2-6010-0041.
VI. CGMP TRAINING
TRAINING IN CURRENT GOOD MANUFACTURING PRACTICES
Training in CGMP's as they relate to the employee's job function shall
be included in the training curriculum for each job classification.
For more information refer to SOP #2-6010-0042.
VII. NEW TECHNOLOGY (EQUIPMENT AND SYSTEMS)
In addition to scheduled ongoing training activities, each Division
Manager shall also be responsible for insuring that appropriate
training is provided whenever new equipment or systems are installed
in their area.

A. P&E UNIT PROJECTS
It shall be the responsibility of the P&E Unit Project Leader to
arrange for and insure that necessary training is provided for
personnel who will be responsible for operation and maintenance of
any equipment or systems installed through project activities.
The development of a training program and plan shall be considered
an integral part of all projects and the project will not be
allowed to be closed out until the training plan and materials
have been approved by the Customer Department, the appropriate
Division Manager, and/or the area Technical Training Specialist.
It is therefore recommended that the area Technical Training
Specialist be involved as a team member or an ad hoc project team
member to help evaluate the need for training and to insure that
proper training materials are prepared. For more information
refer to SOP #4-6490-0007.
B. PACKAGING EQUIPMENT SELECTION
The assigned Packaging Engineer shall be responsible for arranging
and insuring that operation and maintenance training is developed
and made available prior to production start up for all equipment
purchases. For more information refer to SOP #4-6420-0080.
C. REQUESTS FOR ENGINEERING SERVICES (RES)
The Project Engineer in cooperation with the Customer Department
Division Manager, the area Technical Training Specialist, the
Department Head of the Production Equipment Support and the
Department Head of Plant Facilities and Services shall be
responsible for insuring that initial start-up training for
operators, line mechanics and maintenance personnel is provided.
It shall be the responsibility of the Department Head to insure
that on going training and job skill tests are developed to verify
operator proficiency.
D. DIRECT PURCHASE EQUIPMENT AND SYSTEMS
The Division Manager requesting the materials shall be responsible
for insuring that initial start-up training is available for all
direct purchases that are not covered by a P&E Unit Project, a
Packaging Engineering Equipment Selection or a Request for
Engineering Service.
E. RESTRICTED JOB ROTATION DURING START-UP
For major new automated systems and equipment installations,
operators and mechanical staff may be dedicated to the operation

for up to one year to insure clear understanding and thorough
evaluation of the system prior to across the board training of
other personnel. This "restricted period" should provide time to
learn unique features of the equipment, to debug operating
problems and to revise training manuals and materials to reflect
actual operating requirements. It shall be the responsibility of
the affected department heads (Production, PES, PF&S) and the
engineer or project team leader to agree to the need for a
"Restricted Operations Period" and to the time when restrictions
can be lifted and cross training of other personnel can begin.
VIII. COURSE DEVELOPMENT AND EXECUTION
The Site Training and Development Department will provide the
necessary support for technical training as required by P&E
supervision. To this end, courses will be executed in-house and
identification of courses presented by external services will be given
to area managers for use in their respective departments.
3.0 Training Frequency: C
Training applicability and intervals for this SOP will be determined
by area supervision.
4.0 List of SOP Cross References
SOP #2-6010-0041, "SOP Training, Testing and Follow-Up"
SOP #2-6010-0042, "CGMP Training Program for Greenville Site
Employees"
SOP #2-6490-0007, "Process Equipment Selection and Installation
Procedure"
SOP #2-6420-0080, "Issue of the New Packaging Equipment Technical
Training Manual"
5.0 List of Reviewers
Anderson
Conover
Foreman
Gaynor
Hodges
Lavia
Perry

Renn
Williams
Wynne
6.0 Initial Distribution List
Senior Vice President, P&E Unit
Vice President, Production
Vice President, Engineering
Vice President, Logistics
Director, MMD
General Manager, Greenville Site
Manager, OH&S
Manager, Human Resources
All P&E Managers
All P&E Department Heads
All Technical Training Specialists
SOP Administrator, Engineering (9)
Supervisor, Operative Technical Training, ST&D
SOP Admin., Pkg. Training Copy
Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE
Table of Contents . . . . . . . . . . . . . . . . . . . . . . . CONTENTS
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0
Training Frequency: C . . . . . . . . . . . . . . . . . . . . . . 3.0
List of SOP Cross References . . . . . . . . . . . . . . . . . . . . 4.0
Appendix A. Sample SOP Training Plan . . . . . . . . . . . . . . . A.0
Appendix B. SOP Training, Testing and Follow-Up Flowchart . . . . . B.0
FIGURES Figures
ID: 2-6010-0041 EFFECTIVE: 02/27/91
PICTURE 1 SUPERSEDES NO.
4-6010-0041
DATED: 03/01/90
DEPARTMENT(S) IMPACTED: ST&D

TITLE: SOP Training, Testing and Follow-Up
02/19/xx
ST&D Supv.
02/19/xx
Sr. V.P.
2/26/xx
Comp. Adm. Spec.
Issued by: Supv. SOP Oper. 02/26/xx

1.0 Purpose
The purpose of this procedure is to specify the manner in which SOP
training for P&E operative employees will be developed, conducted and
coordinated.
2.0 Procedure
I. SCOPE
This procedure pertains to operational SOPs which are defined as SOPs
that impact upon the identity, strength, quality and purity of a drug
product, component, or packing material. Operational SOPs are
identified by an SOP number with a first digit of 1 or 2.
II. RESPONSIBILITY
Training and retraining of operative employees on SOPs is a primary
responsibility of the first line supervisor. ST&D and the Technical
Training Specialists will provide support to supervision in
fulfillment of this responsibility. To comply with CGMP and ensure
qualified employees, the following procedure should be followed.
III. FREQUENCY OF SOP TRAINING
Employees who transfer into jobs for which they are not already
qualified must be trained on all SOPs relevant to that job during
their initial training period. As new SOPs are developed or revised,
training will be necessary before an employee can perform the
procedure.
In addition, refresher training will be provided on an on-going basis.
All SOPs relevant to the job require refresher training at least once
every two calendar years (some more frequently). The specific
training frequency for an SOP should be specified in the SOP under the
heading "Training Frequency."

IV. TRAINING PLAN DEVELOPMENT
A. Plan Development
SOP Training plans will be developed for operational SOPs which
directly impact operative level employees. Training plans should
include instructions and materials to adequately deliver and
evaluate training. (See sample in Appendix A, "Sample SOP
Training Plan" in topic A.0.)
B. Test Validation
1. All training plans will include a concluding exercise or test
designed to assess the trainee's knowledge and/or skill
concerning items that are important to job performance. Tests
may take several forms: pen and paper, competency (task
demonstration), or a combination of both.
2. SOP tests will be assessed for content validity and
reliability by the Technical Training Specialists using a
minimum of three subject matter experts (SME). SMEs will be
identified by department management and/or the SOP writer.
All SMEs will be asked to evaluate a pool of test items
related to an SOP. Each SME will rate each test item
according to one of two categories: 1) Important to job
performance, 2) Not important to job performance. Based on
the SMEs ratings, a content validity ratio (CVR) will be
calculated on each test item. Only items that have been rated
as important to job performance, based on the CVR rating
system established, will be used in SOP tests.
3. The test validation process is an on-going effort. Test
results will be periodically analyzed to provide additional
validity and reliability data. Test items will be analyzed on
an on-going basis. Poor test results on a test item or
section by a substantial number of employees will trigger a
review of that item(s) by the Technical Training Specialist.
After review, that item/section may be invalidated and
training material revised as necessary.
C. Grouping SOPs
Related SOPs may be grouped together into one training plan and
test. This might be appropriate for a cluster of cleaning SOPs on
several rooms/lines or for a chain of SOPs that cover a sequence

of events regarding a process. The Technical Training Specialist
should look at all SOPs in their areas and determine where
grouping SOPs may be feasible. As with other training plans,
content validation and approval by department management is
required.
D. Segmented SOPs
Some SOPs may contain sections that apply to different work groups
e.g. lineworkers or group leaders. In these instances, the test
should contain sections that are designated for each particular
group. In order to encourage everyone to understand the full
scope of the SOP, employees will be asked to take the complete
test but will be held accountable only for the section(s) that
pertain to their job.
V. CONDUCT OF TRAINING
A. Preparation
SOP trainers should review all training materials (training plan,
SOP, test questions and answers) prior to conducting a training
session. The trainer must also ensure that adequate time has been
scheduled to conduct the training. The estimated training time
can be found on each SOP training plan. The trainer is also
responsible for ensuring all materials, equipment and a suitable
location have been arranged.
Several courses designed to enhance a trainer's skills in
delivering training are available through the Site Training and
Development (ST&D) Department.
B. Conduct
Training on operational SOPs should be conducted using the SOP
training plans that have been developed and/or revised by the area
Technical Training Specialist and approved by department
management.

C. Test Administration
At the conclusion of a SOP training or retraining session, a
validated test should be administered by the trainer to assess
each employee's knowledge, understanding and/or skill concerning
the SOP. After the tests have been completed and collected by the
trainer, the test items and correct answers must be reviewed and
discussed with all participants before concluding the session or
beginning training on another SOP. All tests must be forwarded to
the Technical Training Specialist upon completion of the training
session.
D. Grading
Pen/paper tests must not be graded by the training participants
themselves. These tests should be graded by either the trainer,
supervisor or Technical Training Specialist. The individual
responsible for grading the tests must be determined before the
training session. If the supervisor does not grade the test, the
grader should provide to the supervisor the names and grades of
those who performed below the cutoff score so that follow up
training can be scheduled. Tests must be graded by the end of the
next work day. Test results will remain confidential at all times
and will become part of the training documentation.
Competency (task demonstration) tests should be graded immediately
upon test completion and feedback provided to the test
participant. Follow-up training, if necessary, should be
conducted according to VI.B of this SOP.
E. Cutoff Scores
Cutoff scores for SOP tests will be specified in the training
plan. A cutoff score of 70% should be established for pen and
paper tests. All competency (task demonstration) tests must
require a cutoff score of 100%. Employees who don't meet or
exceed the cutoff score on a test will not be considered
"qualified" on that SOP(s). Test performance below the cutoff
score will require follow-up training and another test. Employees
who have not been qualified on an SOP will not be allowed to work
independently until qualification is completed. This means that
the supervisor must ensure that another qualified employee is
responsible for coaching and/or monitoring the employee's
performance on this procedure during the interim period.

VI. DOCUMENTATION AND FOLLOW-UP
A. Documentation
All SOP training activity must be documented by an attendance log
which is initialed by training participants. SOP training
records, including test results, should be entered into TRIAD.
Test results will be entered into EDMS or TRIAD. Training
attendance will be recorded but qualification will be determined
by test scores. Maintenance of these records is the
responsibility of the area SOP Administrator. The Technical
Training Specialist will serve as back-up for entering and
retrieving records. This documentation must be maintained for
seven years. The Technical Training Specialist must keep all
graded tests in a locked file.
B. Follow-up Training
The supervisor must provide follow-up training and another
validated test to employees who require it as soon as possible and
by the end of the first available work week following the original
test date. Employees who do not successfully complete the second
test should be counseled concerning their progress during training
and an action plan established to correct the deficiency. When
applicable, Employee Relations should be consulted to determine
appropriate action.
This SOP does not require training for operatives.
None
Anderson
Babcock
Conover

Golden
Hodges
Lavia
Mosley
Perry
Renn
Williams
Senior Vice President, P&E Unit
Vice President, Production
Vice President, Engineering
Vice President, Logistics
Director, MMD
Director, CMD
Director, MAIS
General Manager, Greenville Site
All P&E Managers
All P&E Department Heads
All P&E Supervisors
All SOP Administrators
Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0
Cost Center Manager . . . . . . . . . . . . . . . . . . . . . . . 2.1
FIGURES Figures
ID: 2-6010-0042 EFFECTIVE: 07/09/92

2-6010-0042
DATED: 05/21/xx
TITLE: CGMP Training Program for Greenville Site Employees
06/05/xx
ST&D Supv.
06/07/xx
Gen. Site Mgr
06/27/xx
Comp. Adm. Spec.
Issued by: Carney, J. Supv. SOP Oper. 07/08/91

1.0 Purpose
The purpose of this SOP is to outline the minimum CGMP training
requirements for all Greenville Site employees and to provide consistency
in CGMP training activities within and across divisions.
2.0 Procedure
I. RESPONSIBILITY
2.1 Cost Center Manager
CGMP training is the responsibility of the cost center manager. In
performing this responsibility, assistance will be available from
Human Resources, Quality Assurance, and Site Training and Development.
II. TRAINING PROGRAM
The CGMP Training Program will consist of three parts: CGMP
orientation, initial CGMP training and ongoing CGMP refresher
training.
A. CGMP Orientation
The purpose of CGMP orientation is to ensure that all new hires
are aware of CGMPs before they report to their assigned work
areas. All new employees, including temporaries, must attend CGMP
orientation. CGMP orientation will be conducted by the Human
Resources Department during the new employee orientation program.
Upon completion of CGMP orientation, employees should know:
1. The nature of the relationship between the FDA and the
pharmaceutical industry.
2. The philosophy of BW Co. concerning the responsibility of
every employee to ensure quality and FDA compliance.
3. The importance of CGMPs to the production of quality
pharmaceuticals.
4. The importance of SOPs to every job on the Greenville Site.

5. The importance of compliance with CGMPs and the consequences
of non-compliance.
6. The necessity for documentation.
7. The range of CGMP regulations, as outlined in the various
subparts of the Federal Register.
B. Initial CGMP Training
Initial CGMP training is specific training on the subparts of 21
CFR Parts 210 and 211 that relate to a person's job. This
training should begin soon after employment and be complete within
90 days. It is the cost center manager's responsibility to decide
which subparts (if any) are relevant to their employees and to
provide sufficient training in those subparts.
Note
Site Training and Development maintains instructional
materials that may be used to support initial CGMP Training.
C. CGMP Refresher Training
The cost center manager will decide which employees require CGMP
refresher training and will ensure that this training is provided.
All applicable employees must attend a minimum of one CGMP
refresher training session per year. Quality Assurance and Site
Training and Development will develop and deliver CGMP refresher
training sessions. CGMP refresher training sessions should
conclude with a test concerning session content.
Additional CGMP refresher training may be administered by a cost
center provided that the training event is documented per this
procedure.
III. DOCUMENTATION OF TRAINING
A. Responsibility for Documentation
It shall be the responsibility of Human Resources to ensure that
CGMP orientation is documented immediately upon completion.
It shall be the responsibility of the cost center manager to
ensure that initial CGMP training is documented immediately upon

completion.
It shall be the responsibility of ST&D to ensure that CGMP
refresher training is documented immediately upon completion. In
cases where CGMP refresher training is performed by the cost
center, the cost center manager will be responsible for ensuring
that the training event is documented.
B. Attendance Logs
An attendance log, sign-up sheet or equivalent shall be used to
document all CGMP training activities.
At a minimum, this record will contain the subject and/or type of
training, the date and the instructor's name.
Each employee shall verify their attendance and participation in
the training activity by signing or initialing and dating the
appropriate document.
C. Records Retention
Records will be retained for a minimum of seven years from the
date of the training event.
Orientation training records will be maintained by Human
Resources.
Initial CGMP training records will be retained by the cost center
managers.
Refresher CGMP training records will be retained by ST&D.
Note
All training records, including CGMP training, should be
documented on the TRIAD (Training Records, Information and
Documentation) system.

None
Balachandran
Bettis
Cochran
Dev
Golden
Holmes
Locco
Moldin
Powell
Seigler
Williams
Yeowell
All Greenville Cost Center Managers
SOP Administrator, Engineering (9)
Supervisor - Operative Technical Training, ST&D
Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0
Department Head/Supervisor . . . . . . . . . . . . . . . . . . . . 2.1
Supervisor/Trainer . . . . . . . . . . . . . . . . . . . . . . . . 2.2
Supervisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3
TTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.4

FIGURES Figures
ID: 2-6010-0044 EFFECTIVE: 05/26/92
PICTURE 1 SUPERSEDES NO. DATED:
DEPARTMENT(S) IMPACTED: P&E
TITLE: Qualification/Requalification of Production and Engineering
Unit Operative Staff
05/19/xx
ST&DSupv.
05/06/xx
Sr. V.P.
05/12/xx
QADept. Hd.
Issued by: Carney, J. Supv. SOP Oper. 05/19/92
1.0 Purpose
To describe the procedure for qualification/requalification of Production
and Engineering operative staff. This procedure serves as the foundation
for the OPTEC program.
2.0 Procedure

I. INITIAL TRAINING
Includes courses such as HR orientation, work area initial
orientation/training, administrative paperwork, basic batch record
documentation, basic emergency procedures, and basic safety
precautions in the work environment. Testing will be conducted to
verify understanding.
II. STRUCTURED ON-THE-JOB TRAINING
A. After completion of initial training, a new or temporary employee
begins job training under the direct guidance of either a
supervisor, lead person, or experienced operator. During this
period the employee must not perform any critical job function
without direct guidance/supervision until he/she is qualified on
that function. Non-critical job functions are permitted (e.g.
loading/unloading turn tables or conveyors).
B. Courses and SOPs include specific equipment/process cleaning
operations, inspection operations, process monitoring, detailed
batch record documentation, and quality issues. Testing should be
completed on each of the above to ensure knowledge of operation or
level of understanding of the process. After completion of
training, the operator can be scheduled to operate the
equipment/process.
III. QUALIFIED OPERATOR
A. An operator becomes qualified after completion of all required
training (i.e. completed the training curriculum), including all
SOPs required for the job and demonstrates knowledge and skill in
all aspects of the job.
B. Additional courses that may be required for some operative jobs
include: Statistical Process Control, Computer Literacy, HAZCOM,
and Machine/Equipment Safety.
IV. REQUALIFICATION
Due to changes in equipment, processes, and the workforce, it is
necessary to periodically update or renew employee qualifications. In
order to renew qualifications, an operator must:
o demonstrate knowledge and/or skill concerning all SOPs relevant to

the job during the existing or previous calendar year.
o complete training on all major equipment installed since the last
qualification.
o demonstrate competency in a minimum of twelve selected job
skills/tasks for the job.
A. The following represent the steps to be taken for demonstrating
task competency:
2.1 Department Head/Supervisor
2.2 Supervisor/Trainer
2.3 Supervisor
2.4 TTS
2.1 Department Head/Supervisor
1. Select 12 targeted tasks for the new fiscal year.
2. Announce the 12 tasks to operatives in September.
Note
During initial implementation of OPTEC, tasks will be
announced as OPTEC is initially implemented. Dates for
subsequent steps of requalification will be adjusted
accordingly.
2.2 Supervisor/Trainer
3. Begin voluntary assessment of each task for operators
requesting assessment.
2.3 Supervisor
4. If operator does not schedule assessment by December (three

months after initial announcement of targeted tasks), the
supervisor will schedule the assessment.
5. All initial testing should be completed by May with the
exception of those situations where equipment or processes are
not available.
6. Retesting cannot occur the same day as test failure since the
intention of testing is to verify ability to perform the job
repeatedly. Retraining must be provided before retesting.
Retesting should be within one month. The only exception
should be production related situations (e.g. unavailability
of equipment/process).
7. After retraining, a second failure to pass the targeted task
will be treated as a performance problem. Any further
disciplinary action should follow the discipline policy in the
Supervisors Manual.
2.4 TTS
8. The Technical Training Specialist will maintain up-to-date
records for each employee.
9. It is the intention that all 12 targeted tasks be completed
within the fiscal year. Failure to complete this program will
be considered a performance problem and will be reflected in
the summary performance review.
None

Locco
Irwin
Horn
Capps
Clemmons
Ebron
Esarey
Perry
Moore
Charlton

All Department Heads and Above, P&E Unit
Supervisor, OTT, ST&D
All Technical Training Specialist
SOP Administrator, Site
Title Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . TITLE
Figures . . . . . . . . . . . . . . . . . . . . . . . . . . . . FIGURES
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.0
Supervisor, SOP Operations . . . . . . . . . . . . . . . . . . . . 2.1
SOP Administrator . . . . . . . . . . . . . . . . . . . . . . . . 2.2
Author. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.3
Reviewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5
Author. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7
Technical Training Specialist (TTS) . . . . . . . . . . . . . . . 2.9
Supervisor, SOP Operations . . . . . . . . . . . . . . . . . . . 2.10
Approver. . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.11
Supervisor, SOP Operations/Administrative Secretary, SOP Adminis 2.13
Holders of Official SOPs . . . . . . . . . . . . . . . . . . . . 2.14
Author. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.15
Supervisor, SOP Operations/Administrative Secretary, SOP Adminis 2.17
SOP Author. . . . . . . . . . . . . . . . . . . . . . . . . . . 2.18
SOP Author. . . . . . . . . . . . . . . . . . . . . . . . . . . 2.20
ID: 2-6466-0001 EFFECTIVE: 11/6/92
2-6010-0036
DATED: 05/15/92

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