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2018 - Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents
Date2018-12-04
Deadline2018-12-04
VenuePalo Alto, USA - United States 
Keywords21 CFR Part 11 ER ES; Software V&V documentation; Software V&V protocol
Topics/Call fo Papers
Major industry failures
Tougher FDA expectations / requirements
Roles of verification and validation
The 11-element FDA model - and where it's required
A typical software V&V protocol / test report
A brief overview of 21 CFR Part 11, ER / ES
Legacy, hybrid, new, and cloud systems
Expected regulatory deliverables
Complementary guidelines, e.g., GAMP
Tougher FDA expectations / requirements
Roles of verification and validation
The 11-element FDA model - and where it's required
A typical software V&V protocol / test report
A brief overview of 21 CFR Part 11, ER / ES
Legacy, hybrid, new, and cloud systems
Expected regulatory deliverables
Complementary guidelines, e.g., GAMP
Other CFPs
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- Siem Reap 1st International Conference on “Medical, Medicine and Health Sciences” (MMHS- 2018 Siem Reap, Cambodia)
- 6th International Conference on Applied Science and Engineering (ICASE)
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- International Conference on Business Management, Politics, Social Innovation Economics & Humanities (MPSE-April-2019)
Last modified: 2018-07-24 21:34:20