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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 
KeywordsSoftware V&V documentation; 21 CFR Part 11 ER ES; Software V&V template
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
- IRF - International Conference on Smart Technology, Electrical and Electronics Engineering (ICSTEEE - 2019)
- IRF - International Conference on Recent advancement in Medical Education, Nursing, and Health Sciences(ICRAMNH - 2019)
- IRF - International Conference on Civil, Mechanical, Production and Industrial Engineering (ICMPIE - 2019)
- IRF- International Conference on Internet of Things, Big Data Analytics and Information Technology(ICITBDIT - 2019)
- IRF - International Conference on Environmental, Food, Agriculture and Bio-Technology(ICEFABT - 2019)
Last modified: 2018-10-27 16:30:28