Verification vs Validation-Product, Equipment and QMS Software
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Website http://www.compliance4all.com/control/w_product/~product_id=502001LIVE?channel=ourglocal_Aug_2018_SE |
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Category QMS Software, Validation-Product, software quality assurance, iso 9001 software, quality system software, best quality management software, Compliance Solutions
Deadline: August 13, 2018 | Date: August 15, 2018
Venue/Country: Online, U.S.A
Updated: 2018-06-07 14:33:24 (GMT+9)
Call For Papers - CFP
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 expectationsThe Validation Master Plan and its structureProduct Validation - how it differs from process / equipment V&VProcess / Equipment / Facility Validation includingFDA's recent guidanceWho Will Benefit:Senior management in Drugs, Devices, Biologics, DietarySupplementsQARAR&DEngineeringProductionOperationsSpeaker 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 $290.00Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: supportcompliance4All.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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