FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. 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:
- 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
Click here for additional information and registration details.
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