PDA Technical Report No. 35, (TR 35) A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry (single user digital version)

Nov 2001
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.

Many firms today have separate departments with different training requirements. Employees associated with the Microbiological Function do not always receive consistent training. This can lead to varying microbiological control practices within a manufacturing facility.

This Technical Report was produced by the PDA Subcommittee on Microbiology Training, formed in January 2001, to develop an industry vision and guidance for instituting a step-wise, competency-based training program for microbiological training of individuals engaged in work activities connected to contamination control and microbiological testing of pharmaceutical articles.

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Table of Contents

Table of Contents:

1. Introduction
2. The Microbiological Function
3. Understanding Microbiological Concepts
4. Understanding the Rationale, and/or Theory, Associated with Microbiological Concepts and Requirements
5. Microbiological Training Considerations for the Manufacturing Department
6. Training Considerations for the Microbiological Laboratory Testing Department
7. Additional Training Considerations for the Microbiological Function
8. Summary
9. Acknowledgements
Appendix 1: Step-Wise, Competency-Based Training for Manufacturing Personnel - Shown for Illustration Purposes Only
Appendix 2: Step-Wise, Competency-Based Training for Laboratory Personnel - Shown for Illustration Purposes Only
Appendix 3: Reference Materials