Training And Education Within Pharmaceutical Manufacturing Manupharma Summit 4 2005

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Text of Training And Education Within Pharmaceutical Manufacturing Manupharma Summit 4 2005

  • 1.
    • Training and Education
  • within
  • Pharmaceutical Manufacturing
  • David A. Gallup, Ed. D.
  • Principal
  • Training and Communications Group, Inc.

2. Agenda

  • Background
  • Training Review
  • Training Requirements
  • Strategies to Ensure Compliance
  • Is Training Always the Answer?
  • Return on Investment
  • Conclusions

Agenda 3. The End--First

  • Training isnt always the answer.
  • Training must provide a Return on Investment

Agenda 4. Background

  • Personal
  • Training and Communications Group, Inc.

Background 5. What is Training?

  • Change in Behavior to include:
    • Providing new or updated knowledge
    • Providing new or improve skill
    • Changing attitude

Training Review 6. 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 7. 21 CFR 211.25Personnel 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 8. In Summary:

  • Pharmaceutical manufacturers must provide training to their personnel.

Requirements 9. What type of training must be provided? Ensuring Compliance 10. Why are we developing materials this way? Ensuring Compliance 11. Competency-Based Training

  • Identification of required skills or areas of knowledge to perform job
  • Development of training materials to provide:
    • skill development and practice or
    • specific bits of information
  • Implementation of the training materials
  • Evaluation to determine:
    • ability to perform discrete skill or task
    • ability to retain bits of information

Ensuring Compliance 12. What can happen if we dont develop materials this way! Ensuring Compliance 13. Competency-Based TrainingDesign Process Needs Analysis Situation Analysis Task Analysis Objective Specification Implementation Select, Design & Produce Training Materials Select, Design & Produce Evaluation Materials Ensuring Compliance 14. Is Training Always the Answer? Training always the Answer? 15. Training vs. Non-Training Training always the Answer? 16. 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 17. Evaluation Matrix Return on Investment

  • Budget
  • Fewer Rejects
  • Larger Output
  • Reduced Costs
  • Improved Quality
  • Increased Quantity

Stage 3.Results

  • Interview
  • Questionnaire
  • Attitude to program

Stage 2. Reaction

  • Observation
  • Interview
  • Questionnaire
  • Attitude
  • Activity/job


  • Observation Checklist
  • Reports
  • Job Performance
  • Job Behavior


  • Observation
  • Output
  • Test
  • Principles
  • Facts
  • Techniques

Knowledge Stage 1.Trainee Methods of Measure What Can Be Evaluated 18. What is Training?

  • Results of Training Program
  • =
  • Return on investment

Return on Investment 19. 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 20. Reduced Waste Costs/Product Return on Investment 21. Reduced Landfill Costs Return on Investment 22. Savings From Reduced Waste Return on Investment 23. Reduced Non-Conformances Return on Investment 24. Increase in Planning Values Return on Investment 25. Return on Investment Return on Investment 26. The EndReally!

  • Training isnt always the answer.
  • Training must provide a Return on Investment