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2019 - Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
Date2019-06-05
Deadline2019-06-05
VenueOnline Event, USA - United States 
KeywordsRisk; Verification; ComplianceOnline
Topics/Call fo Papers
Verification or Validation -- Current regulatory expectations.
The Master Validation Plan and the Individual V&V Plan.
What is "risk-based"?
Product V&V versus Process / Equipment V&V versus QMS V&V
When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
Using the Risk Management tools of ISO 14971 and ICH Q9
The 11 Elements of the Software VT&V "Model"
Key recent compliance problems
The Master Validation Plan and the Individual V&V Plan.
What is "risk-based"?
Product V&V versus Process / Equipment V&V versus QMS V&V
When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
Using the Risk Management tools of ISO 14971 and ICH Q9
The 11 Elements of the Software VT&V "Model"
Key recent compliance problems
Other CFPs
- U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics
- How to Prepare a Standard Operating Procedure (SOP)?
- How to Conduct Successful Supplier Audits
- Supplier and Service Provider Controls: FDA Expectations
- Legal and Contractual Perspectives of Managing the Remote/Virtual Employee
Last modified: 2019-04-16 23:13:25