Science Researcher Update

Seminar on Verification/Validation - Product, Process, Software & QMS

Written by BCI Staff | Dec 19, 2012 2:39:00 PM

2-day In-person Seminar on Verification/Validation - Product, Process, Software and QMS at Las Vegas - Seminar by GlobalCompliancePanel

Seminar - United States

This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management.
This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources.
It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions.

(Courtesy of tripadvisor.com)

2-day In-person Seminar on Verification/Validation - Product, Process, Software and QMS at Las Vegas - Seminar by GlobalCompliancePanel

Thu, Jan 17, 2013 - Fri, Jan 18, 2013

Hilton Grand Vacations Suites at the Flamingo
  3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109

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