Process Verification and Validation Planning and Execution - Webinar By ComplianceOnline (Medical Devices)
Venue: Online Event
|Event Date/Time: Aug 21, 2012||End Date/Time: Aug 21, 2012|
Why Should You Attend:
FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Why do companies need a Master Validation Plan? What are the must have elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's quality management system.
This webinar will help you develop or refine the company Master Validation Plan to meet FDA / cGMP expectations. It will address the FDA's newer and tougher regulatory stance.
Attendees will learn how to incorporate key principles of the FDA's new Process Validation guidance, to include targeted risk-based V&V planning. We will discuss how you can add the new process validation principles, initiate a Master Validation Plan; evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management; focus on the development of meaningful product, process, facility, and/or QMS validations.
We will also discuss the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or the ASTM E2500 equivalents, against a background of limited company resources. The speaker will present a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 will also be discussed briefly.