Verification vs. Validation - Product, Process, Software and QMS From GlobalCompliancePanel

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GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, “Verification vs. Validation - Product, Process, Software and QMS” on January 17 and 18 at Hilton Grand Vacations Suites at the Flamingo, Las Vegas, Nevada. John E. Lincoln, Medical Device and Regulatory Affairs consultant will be the speaker at this seminar.

Las Vegas, Nevada, USA., January 17 and 18, 2013 - (PressReleasePoint) -

Course Agenda:
The FDA has new and tougher regulatory requirements for a company’s Master Validation Plan for major key inputs and CGMP deficiencies. This seminar will address these. It seeks to demonstrate "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will help participants evaluate these elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management.
In arriving at its goal, this seminar will evaluate aspects such as 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,software VT&Vet al, all to make sure that key FDA requirements are not overlooked. This course will alsoconsider QMS and 21 CFR Part 11, whose practical application will be made during the two days of interactive training.
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About the Speaker:
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations,which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.
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Who will benefit:
This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities/plan(s).This information addresses medical devices, pharmaceutical, diagnostic, and biologics requirements and implementation.

Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website:https://www.globalcompliancepanel.com/
GlobalCompliancePanel
NetZealous
USA Livermore Common, Fremont,
CA 94539, USA
Phone: 1800 425 9407