Training and Education
within
Pharmaceutical ManufacturingDavid A. Gallup, Ed. D.
Principal
Training and Communications Group, Inc.
Agenda
Background Training Review Training Requirements Strategies to Ensure Compliance Is Training Always the Answer? Return on Investment Conclusions
Agenda
The End--First
Training isn’t always the answer. Training must provide a Return on
Investment
Agenda
Background
Personal Training and Communications Group, Inc.
Background
What is Training?
1. Change in Behavior to include:• Providing new or updated knowledge• Providing new or improve skill • Changing attitude
Training Review
What are the Training Requirements?
FDA regulates manufacturing, processing, packaging and holding of drugs in Code of Federal Regulations
CFR contains an important section regarding training: Section 21, Paragraph 211.25
Requirements
21 CFR 211.25 Personnel Qualifications
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions.
Requirements
In Summary:
Pharmaceutical manufacturers must provide training to their personnel.
Requirements
What type of training must be provided?
Ensuring Compliance
Why are we developing materials this way?
Ensuring Compliance
Competency-Based Training
1. Identification of required skills or areas of knowledge to perform job
2. Development of training materials to provide: skill development and practice or specific “bits” of information
3. Implementation of the training materials
4. Evaluation to determine: ability to perform discrete skill or task ability to retain “bits” of information
Ensuring Compliance
What can happen if we don’t develop materials this way!
Ensuring Compliance
Competency-Based Training Design Process
Needs Analysis
Situation Analysis
Task Analysis
Objective Specification
Implementation Select, Design & ProduceTraining Materials
Select, Design & Produce
Evaluation MaterialsEnsuring Compliance
Is Training Always the Answer?
Training always the Answer?
Training vs. Non-Training
Training always the Answer?
How do we measure effect of training?
Immediate Change in behavior Delayed Change in behavior “Goodness” of Training Program Results of Training Program
Return on Investment
Evaluation MatrixWhat Can Be Evaluated Methods of
Measure
Stage 1. Trainee Knowledge PrinciplesFacts Techniques
ObservationOutputTest
Attitude Job PerformanceJob Behavior
Observation Checklist
Reports
Skill AttitudeActivity/job
ObservationInterviewQuestionnaire
Stage 2. Reaction Attitude to program InterviewQuestionnaire
Stage 3. Results Reduced CostsImproved QualityIncreased Quantity
BudgetFewer RejectsLarger Output
Return on Investment
What is Training?
Results of Training Program
=
Return on investment
Return on Investment
Return on Investment
Example:
Reduced waste costs in the granulation area following the completion of a competency-based, technical skill training program for operators and line tenders.
Return on Investment
Reduced Waste Costs/Product
$1,900
$2,000
$2,100
$2,200
$2,300
$2,400
$2,500
1994 1995
Return on Investment
Reduced Landfill Costs
250,000
260,000
270,000
280,000
290,000
300,000
310,000
320,000
330,000
1994 1995
Return on Investment
Savings From Reduced Waste
$0
$100,000
$200,000
$300,000
$400,000
$500,000
$600,000
$700,000
$800,000
$900,000
1994 1995
Return on Investment
Reduced Non-Conformances
0
200
400
600
800
1000
1200
1994 1995
Return on Investment
Increase in Planning Values
0%
5%
10%
15%
20%
25%
1994 1995 1996 1997
Return on Investment
Return on Investment
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
800,000
900,000
1995 1996
Return on Investment
The End—Really!
Training isn’t always the answer. Training must provide a Return on
Investment
Agenda
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