Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements 2015
10 Jun 2015
Webinar
Description
Topics
The Master Validation Plan / structure
Verification or Validation - Recent regulatory expectations
Process / Equipment / Facility Validation - FDA`s new guidance
Product Validation - how it differs from process / equipment V&V
How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
When and How to use DQ, IQ, OQ, PQ, or their equivalents
Incorporating 21 CFR Part 11 requirements
The 11 key documents for software validation
Suggested "test case" formats
Who should Attend
QA
Senior management in Drugs, Devices, Biologics, Dietary Supplements
R&D
RA
Production
Engineering
Consultants; others tasked with product, process, software... validation responsibilities
Operations
Past Events
Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements 2015 - 10 Jun 2015, Webinar (52083)
Important
Please, check "Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements" official website for possible changes, before making any traveling arrangements
