The Company Software Verification and Validation Plan - Webinar By ComplianceOnline (FDA Compliance Train)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jul 12, 2011 End Date/Time: Jul 12, 2011
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his presentation focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and growing "cloud"-based software. A suggested FDA model will be evaluated, implemented, with V&V documentation and test case examples.

The focus will be on the most recent issues the FDA has had in this area, and remediation approaches. Software considered include: 1) In-product, 2) As-product, 3) Production and test, and 4) QMS / 21 CFR Pt. 11. Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.

Areas Covered in the Seminar:

- Recent industry failures.
- Tougher FDA Expectations / Requirements.
- Roles of Verification and Validation.
- An FDA "Model".
- A Typical Software V&V Protocol / Test Report.
- A Brief Overview of 21 CFR Part 11.
- Legacy, Hybrid, New and ER / ES Systems.
- Expected Regulatory Deliverables.

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount.


Online Event
2600 E. Bayshore Road
Palo Alto
United States