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2020 - Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971
Date2020-05-27
Deadline2020-05-17
VenueOnline Event, USA - United States 
KeywordsSoftware validation training; Software validation compliance; FDA Part 11 requirements
Topics/Call fo Papers
U.S. FDA's expectations
Tougher FDA Expectations / Requirements
Data Integrity and Cybersecurity
Roles of Verification and Validation; Legal requirements; Recommended “best practices”
A 21-year long, field-tested FDA "Model"
A Typical Software V&V Protocol / Test Report; "Black" and "White" box testing
21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
Expected Regulatory Deliverables
Major areas of industry failure
Standards and industry-recommended Guidelines
Tougher FDA Expectations / Requirements
Data Integrity and Cybersecurity
Roles of Verification and Validation; Legal requirements; Recommended “best practices”
A 21-year long, field-tested FDA "Model"
A Typical Software V&V Protocol / Test Report; "Black" and "White" box testing
21 CFR Part 11 (electronic records / signatures) requirements, and its implementation
Expected Regulatory Deliverables
Major areas of industry failure
Standards and industry-recommended Guidelines
Other CFPs
- FDA and MHRA Guidance during the COVID-19 Emergency: Medical Devices and Diagnostic Tests
- Medical Device Industry Trends for Computer Systems Regulated by FDA
- Understanding Key Quality System Requirements for Combination Product (Medical device and Pharmaceuticals) Manufacturers
- FDA Inspection Readiness
- Leading and Managing in Virtual Environments and Home Offices
Last modified: 2020-05-07 00:41:10