This course is designed to introduce technicians and professionals to the principles and regulatory requirements for validation documentation in the drug, biologic, and medical device industries. We'll delve into FDA process validation per 2011 FDA Guidance to Industry "Process Validation: General Principles and Practices." Multiple activities nested within the presentation gauge knowledge and group breakouts gauge more application of newly acquired knowledge. The hands-on group breakouts center around a fictitious common pharmaceutical scenario: Process Validation of a Sterilization Process (autoclave).
Manufacture/Production Operators, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineering Personnel
- Concept of validation – why validate?
- Product Life Cycle approach (ICH Q8,Q10, Q9)
- Validation documentation overview
- The importance of validation documentation (document hierarchy starting with Validation Master Plan, V-model: URS, FRS, Design specs, FAT, SAT, IQ, OQ, PQ)
- Documentation exercises
- Apply good documentation practices and technical writing tips to writing different elements of a validation plan
- Explain FDA validation types and documentation expectations
- Define and Identify needed validation elements
- Explain the validation document hierarchy and how it relates to the product lifecycle.
- List different validation guidance documents, standards and resources
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