Process Validation for Medical Device

1. Introduction
2. Process Validation - The FDA Quality Systems Regulation (QSR)
   1. History of Validation
   2. Process Validation Regulations
   3. Definitions
   4. Validation Economics
   5. The Process Validation Model
   6. Elements of Process Validation
   7. When to validate, verify and qualify
   8. Types of Validation
3. Getting Started – Part I
   1. Validation Master Plans
   2. Components of a Validation Master Plan
4. Getting Started – Part II
   1. Steps to Process Validation
   2. Installation Qualification (IQ)
   3. Operational Qualification (OQ)
   4. Validation Tools
   5. Sample size determination
   6. Performance Qualification (PQ)
5. Statistical Techniques and Data Interpretation Overview
   1. Monitoring
   2. Revalidation

 

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