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Jan
18

Verification and Validation - Product, Equipment/Process, Software and QMS

 
 Seminar/trade show (noCPF)

When:

  18 Jan 2022 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  |  406 views

Placement:

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