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      Best Practices to Help you Pass an FDA Computer System (Validation) in Fremont

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      December 7, 2018

      Friday   9:00 AM - 12:00 PM

      161 Mission Falls Lane, Suite 216,
      Fremont, California 94539

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      Best Practices to Help you Pass an FDA Computer System (Validation)

      Overview:This webinar will help you understand the FDA"s current thinking on 
      computer systems that are validated and subject to inspection and audit.
      Areas Covered in the Session:21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)Data Archival to ensure security, integrity and complianceValidation Strategy that will take into account the system risk assessment 
      and system categorization (GAMP V) processesRecent FDA findings for companies in regulated industries
      Who Will Benefit:Anyone who is involved in the development, testing, manufacturing, 
      storage, handling and distribution of product must understand and 
      conform to FDA requirements for data quality and integrity, and computer 
      system validation (CSV)Finally, anyone who is acting as a consultant or contractor to a company 
      in an FDA-regulated industry should attend to ensure they are able to 
      bring the most current knowledge and expertise to their assignment
      Speaker Profile:Carolyn (McKillop) Troiano has more than 35 years of experience in the 
      tobacco, pharmaceutical, medical device and other FDA-regulated 
      industries. She has worked directly, or on a consulting basis, for many of 
      the larger pharmaceutical and tobacco companies in the US and Europe, 
      developing and executing compliance strategies and programs.
      Event Fee: One Dial-in One Attendee Price: US$290.00
      Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email:

      Cost: 290.00

      Categories: Education | Health & Wellness | Technology

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