Software Verification and Validation Planning and Implementation 2012 is a webinar that covers topics such as:
- Tougher FDA Expectations / Requirements
- Recent industry failures
- An FDA "Model"
- Roles of Verification and Validation
- A Brief Overview of 21 CFR Part 11
- A Typical Software V&V Protocol / Test Report
- Expected Regulatory Deliverables
- Legacy, Hybrid, New and ER / ES Systems
- Complementary Guidelines, e.g., GAMP
Software Verification and Validation Planning and Implementation 2012 brings together attendees fromPharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields including Regulatory affairs, Senior management, Production / QAE, Quality Assurance, Engineering, R&D, and software development and testing teams.
