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2018 - Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents
Date2018-06-19
Deadline2018-06-18
VenueCity- Palo Alto, State- CA, USA - United States 
KeywordsSoftware; 21 CFR Part 11 CGMP; V&V activities; FDA
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
- 15th World Congress on Structural Biology
- 49th International Conference on Advanced Nursing Research
- International Conference on Energy Applications, Biotechnology, Applied Science and Engineering Research-EBAE
- International Conference on Design, Architecture, Agriculture, Engineering Sciences and Application of IT-DAEAI
- International Conference on Technological Development in Information Technology Engineering Networks and Aviation Technology-TINA
Last modified: 2018-06-02 19:47:37