Course Content:
- Introduction & Course Objectives
- Introduction
- Business Benefits of Equipment Validation
- Regulatory Requirements & Guidelines
- Validation Master Plan
- Validation versus Verification
- Statistical Methods & Tools for Validation
- ISO 14971 & Risk Assessment
- Equipment Qualification (IQ, OQ, PQ)
- Cleaning Validation
- Product & Process Validation
- 21 CFR Part 11 – Electronic Signatures & Records
- Case study & exercise
- Preparing a Validation Master Plan
- Preparing a Equipment Validation Protocol
- Preparing a Process Validation Report
- Maintaining a state of validation
- Retrospective Validation
- Review of recent FDA Warning Letters
- Q&A
- Conclude & Follow Up Process
