2020 - Trends in FDA Compliance and Enforcement for Regulated Systems

Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
Learn about the importance of doing a risk assessment of all FDA-regulated systems
Learn about the importance of categorizing your FDA-regulated software according to GAMP 5 guidelines
Understand “GxP” Systems
Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
Learn how Data Archival plays a key role in ensuring security, integrity and compliance
Learn how to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes
Learn about recent FDA findings for companies in regulated industries, specifically related to computer systems, validation, 21 CFR Part 11 and data integrity
Understand the latest guidance from FDA on data integrity
Learn about recent trends in technology that need to be addressed in the CSV approach
Learn about industry best practices for becoming inspection ready
Q&A