Share Your Research, Maximize Your Social Impacts
Main Menu
Searching By
PARTNERS
2019 - Software Validation and its 11 Key Documents
Date2019-04-17
Deadline2019-04-17
VenueOnline Event, USA - United States 
KeywordsSoftware validation; Validation documentation; Fda model
Topics/Call fo Papers
Major areas of industry failure
Tougher FDA Expectations / Requirements; Cybersecurity
Roles of Verification and Validation
An FDA "Model"
A Typical Software V&V Protocol / Test Report; "Black" and "White" box
A Brief Overview of 21 CFR Part 11, and its implementation
Legacy, Hybrid, New and ER / ES Systems
Expected Regulatory Deliverables
Complementary Guidelines
Tougher FDA Expectations / Requirements; Cybersecurity
Roles of Verification and Validation
An FDA "Model"
A Typical Software V&V Protocol / Test Report; "Black" and "White" box
A Brief Overview of 21 CFR Part 11, and its implementation
Legacy, Hybrid, New and ER / ES Systems
Expected Regulatory Deliverables
Complementary Guidelines
Other CFPs
- Human Factors Usability Studies Following ISO 62366 and FDA Guidance
- Excel Spreadsheet Validation-Step-by-step guide to data integrity compliance
- The Importance of Packaging and Labeling in Pharmaceutical Production – Best Practices
- CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture
- Win-Win Negotiations
Last modified: 2019-04-02 20:58:02