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Verification vs Validation-Product, Equipment and QMS Software
Presented By Netzealous LLC DBA - Compliance4All
Wednesday, August 15th at 8:00am PST
Online sale ends: 08/15/18 at 7:00am PST
Online
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Fremont, CA 94539
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Description
Overview: You will learn What do the U.S. FDA and EU Expect for Verification and Validation, Actions and documentation to meet U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements, ISO 14971 and IEC 62366 considerations, as appropriate. Why should you Attend: The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. Why "working definitions"? What's a field proven approach. Requirements to qualifications to test cases to the validation. Areas Covered in the Session: Verification or Validation Recent regulatory expectations The Validation Master Plan and its structure Product Validation - how it differs from process / equipment V&V Process / Equipment / Facility Validation including FDA's recent guidance Who Will Benefit: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Speaker Profile: John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, 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 described in peer-reviewed technical articles, and workshops, world wide. Event Fee: One Dial-in One Attendee Price: US $290.00 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com |
Presented By
8:00am to 11:00am
General Admission: $290.00
All Ages
50 18004479407 UPCOMING EVENTS
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