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Training And Education Within Pharmaceutical Manufacturing Manupharma Summit 4 2005


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Training And Education Within Pharmaceutical Manufacturing Manupharma Summit 4 2005

  1. 1. <ul><li>Training and Education </li></ul><ul><li>within </li></ul><ul><li>Pharmaceutical Manufacturing </li></ul><ul><li>David A. Gallup, Ed. D. </li></ul><ul><li>Principal </li></ul><ul><li>Training and Communications Group, Inc. </li></ul>
  2. 2. Agenda <ul><li>Background </li></ul><ul><li>Training Review </li></ul><ul><li>Training Requirements </li></ul><ul><li>Strategies to Ensure Compliance </li></ul><ul><li>Is Training Always the Answer? </li></ul><ul><li>Return on Investment </li></ul><ul><li>Conclusions </li></ul>Agenda
  3. 3. The End--First <ul><li>Training isn’t always the answer. </li></ul><ul><li>Training must provide a Return on Investment </li></ul>Agenda
  4. 4. Background <ul><li>Personal </li></ul><ul><li>Training and Communications Group, Inc. </li></ul>Background
  5. 5. What is Training? <ul><li>Change in Behavior to include: </li></ul><ul><ul><li>Providing new or updated knowledge </li></ul></ul><ul><ul><li>Providing new or improve skill </li></ul></ul><ul><ul><li>Changing attitude </li></ul></ul>Training Review
  6. 6. What are the Training Requirements? <ul><li>FDA regulates manufacturing, processing, packaging and holding of drugs in Code of Federal Regulations </li></ul><ul><li>CFR contains an important section regarding training: Section 21, Paragraph 211.25 </li></ul>Requirements
  7. 7. 21 CFR 211.25 Personnel Qualifications <ul><li>(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. </li></ul>Requirements
  8. 8. In Summary: <ul><li>Pharmaceutical manufacturers must provide training to their personnel. </li></ul>Requirements
  9. 9. What type of training must be provided? Ensuring Compliance
  10. 10. Why are we developing materials this way? Ensuring Compliance
  11. 11. Competency-Based Training <ul><li>Identification of required skills or areas of knowledge to perform job </li></ul><ul><li>Development of training materials to provide: </li></ul><ul><ul><li>skill development and practice or </li></ul></ul><ul><ul><li>specific “bits” of information </li></ul></ul><ul><li>Implementation of the training materials </li></ul><ul><li>Evaluation to determine: </li></ul><ul><ul><li>ability to perform discrete skill or task </li></ul></ul><ul><ul><li>ability to retain “bits” of information </li></ul></ul>Ensuring Compliance
  12. 12. What can happen if we don’t develop materials this way! Ensuring Compliance
  13. 13. Competency-Based Training Design Process Needs Analysis Situation Analysis Task Analysis Objective Specification Implementation Select, Design & Produce Training Materials Select, Design & Produce Evaluation Materials Ensuring Compliance
  14. 14. Is Training Always the Answer? Training always the Answer?
  15. 15. Training vs. Non-Training Training always the Answer?
  16. 16. How do we measure effect of training? <ul><li>Immediate Change in behavior </li></ul><ul><li>Delayed Change in behavior </li></ul><ul><li>“Goodness” of Training Program </li></ul><ul><li>Results of Training Program </li></ul>Return on Investment
  17. 17. Evaluation Matrix Return on Investment <ul><li>Budget </li></ul><ul><li>Fewer Rejects </li></ul><ul><li>Larger Output </li></ul><ul><li>Reduced Costs </li></ul><ul><li>Improved Quality </li></ul><ul><li>Increased Quantity </li></ul>Stage 3. Results <ul><li>Interview </li></ul><ul><li>Questionnaire </li></ul><ul><li>Attitude to program </li></ul>Stage 2. Reaction <ul><li>Observation </li></ul><ul><li>Interview </li></ul><ul><li>Questionnaire </li></ul><ul><li>Attitude </li></ul><ul><li>Activity/job </li></ul>Skill <ul><li>Observation Checklist </li></ul><ul><li>Reports </li></ul><ul><li>Job Performance </li></ul><ul><li>Job Behavior </li></ul>Attitude <ul><li>Observation </li></ul><ul><li>Output </li></ul><ul><li>Test </li></ul><ul><li>Principles </li></ul><ul><li>Facts </li></ul><ul><li>Techniques </li></ul>Knowledge Stage 1. Trainee Methods of Measure What Can Be Evaluated
  18. 18. What is Training? <ul><li>Results of Training Program </li></ul><ul><li>= </li></ul><ul><li>Return on investment </li></ul>Return on Investment
  19. 19. Return on Investment <ul><li>Example: </li></ul><ul><li>Reduced waste costs in the granulation area following the completion of a competency-based, technical skill training program for operators and line tenders. </li></ul>Return on Investment
  20. 20. Reduced Waste Costs/Product Return on Investment
  21. 21. Reduced Landfill Costs Return on Investment
  22. 22. Savings From Reduced Waste Return on Investment
  23. 23. Reduced Non-Conformances Return on Investment
  24. 24. Increase in Planning Values Return on Investment
  25. 25. Return on Investment Return on Investment
  26. 26. The End—Really! <ul><li>Training isn’t always the answer. </li></ul><ul><li>Training must provide a Return on Investment </li></ul>Agenda