Interfacing Design Verification, Process Validation and Design Validation
Overview:
There is confusion between the requirements for Design Verification, Process Validation and Design Validation.
While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements.
Areas Covered in the Session:
- Requirements for Design Verification.
- What is "successful Design Verification"?
- Requirements for Process Validation
- What are the inputs to Process Validation from Design?
- What are the requirements for Design Validation?
- Where do I get "production products" for Design Validation?
- What is the impact of Design Change during Design Verification? Process Validation? Design Validation?
Who Will Benefit:
- Design Engineers and Managers
- Project Managers
- Quality Engineers and Managers
- Process Engineers and Managers
- Regulatory Affairs