Topics
- Recent regulatory expectations
- Verification and Validation, differences and how they work together
- Key "milestones" and "tasks" in a project
- How to document a " risk -based" rationale, and use it in a resource-constrained environment
- Compile "generic" and Individual Validation Plans
- And document key subject "inputs"
- How to develop Process and/or Production/ Test Equipment VV Files/Protocols
- The key element of a Product VV File /Protocol
- Sample sizes and their justification
- A grasp of basic Test Case construction
- Hardware and software vendors, sales and marketing
- The key elements of Software VV expected by the FDA and how to document
- How to compile QMS Electronic Records and Electronic Signatures VVs to satisfy 21 CFR Part 11
- A field-tested software VV documentation "model"
Who should Attend
Attendees from medical devices, pharmaceutical, diagnostic, and biologics companies involved in:
- Regulatory Affairs
- Senior and middle management and staff
- QA/QC
- Quality Assurance or Quality Control Professionals
- R&D
- IT/IS
- Manufacturing Engineers
- Production Management
- Software Engineers
- Process Engineers
- Hardware and software vendors, sales and marketing
- Project Managers
