3-Hour Virtual Seminar on Best Practices to Help you Pass an FDA Computer System Validation Audit 2019

Topics

• 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

Who should Attend

Attendees with responsibilities in:

• Consultanting or contractor to a company in an FDA-regulated industry
• Development, testing, manufacturing, storage, handling ,distribution of product