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2020 - 21 CFR Part 11 and QMS Software Risk-Based Implementation



VenueOnline event, USA - United States USA - United States

KeywordsCGMPs; ISO 13485; CGMPs


Topics/Call fo Papers

U.S. FDA's expectations / requirements
Recent Data Integrity and Cybersecurity regulatory requirements
Roles of Verification and Validation; Legal requirements; Recommended “best practices”
The development of a 21-year long, field-tested FDA "Model"
Basic development, implementation, use, and decommissioning expectations
21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
Expected Regulatory Deliverables
Applicable standards and industry-recommended Guidelines

Last modified: 2020-10-06 17:29:07