3-Hour Virtual Seminar on Master Validation Plan - The Unwritten Requirements
Added by Compliance4all on 2018-05-17
Conference Dates:
Start Date: 2018-06-20Last Day: 2018-06-20
Deadline for abstracts/proposals: 2018-06-20
Conference Contact Info:
Contact Person: NetZealous LLC, DBA compliance4AllEmail: [email protected]
Address: Online event, Fremont, CA, 94539, United States
Tel: 800-447-9407
Conference Description:
Overview: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.