Best Practices to Help you Pass an FDA Computer System (Validation)

Overview: This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit. Areas Covered in the Session: 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES) Data Archival to ensure security, integrity and compliance Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes Recent FDA findings for companies in regulated industries