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      Latest Master Validation Plan - The Unwritten Requirements in Fremont


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      June 18, 2019

      Tuesday   9:00 AM - 12:00 PM

      Fremont, California, United States
      Fremont, California

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      EVENT DETAILS
      Latest Master Validation Plan - The Unwritten Requirements

      Overview:
      FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.

      Why should you Attend:
      Verification and validation requirements have always been part of the US FDA's GMPs.However, with increasing technology, both industry and regulatory agencies expectations have increased.

      Areas Covered in the Session:
      The 11 key documents for software validation
      Incorporating 21 CFR Part 11 requirements
      Suggested "test case" formats

      Who Will Benefit:
      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.

      Event Fee: One Dial-in One Attendee Price: $290.00

      Contact Detail:
      Compliance4All DBA NetZealous,
      Phone: +1-800-447-9407
      Email: compliance4all14@gmail.com

      Cost: Payment required - $290 Live $490 Corporate Live

      Categories: Conferences & Tradeshows | Education | Health & Wellness

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.