The 3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit 2019 is a webinar that covers topics such as:
- GxP – Good Manufacturing, Laboratory and Clinical Practices
- Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
- Data Archival to ensure security, integrity and compliance
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- Recent FDA findings for companies in regulated industries
- Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
- Interactive Q&A Session
- The resources, documentation and room preparation necessary to adequately prepare for inspection
The 3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit 2019 is intended for attendees with responsibilities in:
- Consultanting or contractor to a company in an FDA-regulated industry
- Development, testing, manufacturing, storage, handling ,distribution of product
