Drug Master Files (DMF's) - Understanding and Meeting Your Regulatory and Processing Responsibilities

Instructor: James Harris(PhD)
Product ID: 701704
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2010

Training CD / USB Drive

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CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

In this Drug Master Files (DMF's) training learn how and why the DMF's is submitted to FDA and how it intended to be used.

Why Should You Attend:
A Drug Master File is a submission of information to FDA by a person or organization who intends it to be used by others for one of several different purposes. To facilitate this use, FDA has defined five types of drug master files each of which has been defined for a specific purpose. The file may contain information of the kind required for the submission to the agency. This program will explain in detail what a drug master file entails, how and why it is submitted to FDA, and how it is intended to be used. It is important to understand that a DMF is not a substitute for and IND, NDA, ANDA or Export Application. It is intended to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file.

Areas Covered in the Seminar:
  • Introduction.
  • Definitions.
  • Types of Drug Master Files.
  • Submissions to Drug Master Fines.
  • Drug Master File Contents.
  • Format, Assembly and Delivery.
  • Authorization ro Refer to a DMF.
  • Processing and Reviewing Policies.
  • DMF Holder Obligations.
  • Transfer of Ownership.
  • Closure of a DMF.

Who Will Benefit:
  • Regulatory affairs managers & directors for pharma manufacturers and their suppliers
  • Manufacturing
  • Research and Development
  • Quality Assurance & Control
  • Validation
  • Development and Preparation of Submission Materials

Instructor Profile:
James R. Harris, has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. He has advised manufacturers around the globe about DMFs and has aided in the creation of many such documents.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

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