Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents 2018 is a webinar dedicated to the documentation required by the U.S. FDA for the verification and validation planning and execution .
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents 2018 covers topics such as:
- Tougher FDA expectations / requirements
- Major industry failures
- The 11-element FDA model - and where it`s required
- Roles of verification and validation
- A brief overview of 21 CFR Part 11, ER / ES
- A typical software V&V protocol / test report
- Expected regulatory deliverables
- Legacy, hybrid, new, and cloud systems
- Complementary guidelines, e.g., GAMP
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents 2018 intended for:
- Regulatory affairs
- Senior management
- Production
- Quality assurance / QAE
- R&D
- Engineering
- All personnel involved in a U.S. FDA-regulated environment
- Software development and testing teams
- Companies with quality management / MRP / ERP systems moving toward paperless systems or other regulated medical products activities
- Those involved in new product development with products and equipment that are software driven
