Trends in FDA Compliance and Enforcement for Regulated Systems will provide the attendees with the opportunity to learn about Computer System .. Read more 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), and learn how Data Archival plays a key role in ensuring security, integrity and compliance.
Carolyn TroianoERP Project Manager, City of Richmond
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