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
- "generic" Master and Individual Validation Plans
- Key subject "inputs"
- How to develop Process and/or Production/Test Equipment V&V Files/Protocols
- Key element of a Product V&V File/Protocol
- Sample sizes and their justification
- Get a grasp of basic Test Case construction
- Hardware and software vendors, sales and marketing field-tested software V&V documentation "model"
- Key elements of Software V&V expected by the FDA and how to document
- How to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11
Who should Attend
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 and any professional tasked with V&V responsibilities from Pharmaceutical, Medical Devices, Biologics and Diagnostic companies.
