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      6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities in Fremont


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      September 29, 2020

      Tuesday   8:00 AM - 2:00 PM

      Online event
      Fremont, California 94539

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      EVENT DETAILS
      6-Hour Virtual Seminar on The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

      This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

      Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

      The course will include the current review and enforcement climate within FDA and the manner, in which Drug Master Files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

      Cost: Payment required - https://www.gcplearning.com/virtual-seminar/6-hour-virtual-seminar-on-the-use-of-drug-master-files-&-quality-agreements:-understanding-and-meeting-your-regulatory-and-processing-responsibilities-11493LIVE

      Categories: Conferences & Tradeshows

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

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