A list of possible topics to be covered on a computerised system validation course.
Possible Topics to be Covered:
Key Terms and Definitions
Regulations and Guidelines
System Development Life Cycle
Medical Device Regulations
Revalidation: All or Part of the System?
Electronic Signatures and Electronic Records: 21 CFR 11
Workshop on Electronic Signatures and Electronic Records
Keeping a System Validated when Operational
So You Think You are Compliant?
System Retirement and Data Migration
Review of the Course