Search a Conference through our dedicated search page

Things To Do Immediately About Master Validation Plan 2019

29th January 2019   -   29th January 2019
Fremont - Webinar, United States
https://www.compliance4all.com/control/w_product/~product_id=502268LIVE?channel=conference-service_Jan_2019_SEO
Save

Abstract

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols. How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, against a background of limited company resources (personnel, budget, time). A matrix simplifies "as-product", "in-product", process, and equipment, et al, software V&VT, assuring key FDA requirements are not overlooked. What is the FDA definition of "risk based" and how is it documented in the V&V test report. Additional recommended supporting systems / documentation. The QMS / CGMP and 21 CFR Part 11 must also be considered.

Related Fields