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      IoPP-PR: A Discussion on FDA's Anticipated Draft Guidance in Caguas


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      August 22, 2019

      Thursday   6:30 PM

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      EVENT DETAILS
      IoPP-PR: A Discussion on FDA's Anticipated Draft Guidance

      Join the discussion!   A Discussion on FDA’s Anticipated Draft Guidance: Computer Software Assurance for Manufacturing, Operations, and Quality System Software DATE AND TIME 08/22/19 7:00pm - 08/22/19 9:30pm Registration from 6:30pm   SPEAKER Sandra RodríguezLS Industry Veteran and Market Analyst Axendia, Inc.  LinkedIn Profile   When the Medical Devices Current Good Manufacturing Practice (CGMP) Final Rule, Quality System Regulation, became effective on June 1, 1997, they had an “unintended consequence”: Validating Computer Systems to death!  On the 15th of May 2018, approximately 21 years after the start of the CSV cold war, FDA and industry metaphorically declared that it is time to stop validating computer systems to death. As a result, a new draft guidance will soon be released. In this presentation, Sandra K. Rodriguez, Market Analyst at Axendia will explain why critical thinking is the foundation of computer system assurance.   Important updates will be announced by email.    Dress CodeBusiness Attire MapC3Tec in Google Maps TicketNo printed ticket required.  PaymentsPayments are being processed through Eventbrite. If you experience any trouble in the process, contact us to give you options.    Terms and conditionsAll event sales are final. There are no refunds, no cancellations, no credits and no exchanges after the reservation has been made.        For more information contact us. iopppr@gmail.com

      Categories: Science

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