Conference Description:

Overview:

Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.

You'll come away with an actionable understanding of:

Developing and creating buy-in for a project validation plan
Understanding what the FDA accepts as an appropriate documentation model
Beyond just in-product software V&V - understanding FDA's expectation for your testing software, ERP software and more
When and how to use DQ, IQ, OQ, PQ or their equivalents
How GAMP 4/5 requirements fit into your V&V planning and execution
Detailing the FDA's 11 key V&V documentation elements:
Level of concern
Hazard/Risk analysis
Software description
SRS (Software Requirements Specification)
Architecture
Design specification
Traceability (Matrix; Paragraph Numbering)
Development
V&V (Verification/Testing & Validation: IQ, OQ, Part 11 test cases, if required, PQs)
Revision history and release number
Unresolved anomalies ('Bugs')

Event link : http://www.compliance4all.com/control/w_ product/~product_id=501967LIVE?channel=w orldconferencecalendar-june_2018_SEO
Contact Details:
NetZealous LLC, DBA compliance4All
Phone: +1-800-447-9407
Email: [email protected]