When: |
18 Jan through 19 Jan 2022 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.complianceonline.com/verification-and-validation-product-equipment-software-and-qms-seminar-training-80058SEM-prdsm?channel=Brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Medicine & Health - Pharmaceutical / Medicinal |
Keywords:
Event description:
Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning:
Start with a Master Validation Plan;
Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management;
The Individual V&V Plan;
V&V Project Management;
“Risk-based” per ISO 14971, ICH Q9, and/or GAMP/JETT;
Two key input analysis tools;
Change control and “drawing a line in the sand”;
Develop meaningful V&V Files and Protocols for:
Products;
Process;
Production Equipment;
Monitoring and Test Equipment;
Learning Objectives:
Understand Verification and Validation, differences and how they work together
Develop a “Working Definition” of V&V, Qualification, and related terms
Discuss recent regulatory expectations
How to document a “risk-based” rationale, and use it in a resource-constrained environment
Determine key “m...
Read more
Posting date:
22 November 2021 | 180 views
Placement:
Not-featured (How do I make my event featured?)
Flag (Report this event)