Webinars >>Vendor Validation
Drug Master Files – Helping with FDA DMFs

​A Drug Master File (DMF) is a submission to the FDA of information, usually concerning the confidential detailed information about Chemistry, Manufacturing and Controls (CMC) of a drug product or a component of a drug Product. The DMFs form an integral part of interactions between vendors and clients.

This webinar will discuss the current review and enforcement policy of the drug master files (DMFs) within the FDA. It will also cover the administrative aspects of managing a Drug Master File (DMF).
​Why you should attend?

Ensuring the high quality DMF is critical to assure that it be utilized appropriately. The DMF holders have the responsibility to assure that their DMF is current and complete. This webinar will discuss the current FDA policies regarding the DMF and will cover a wide range of topics of interest to DMF holders such as manufacturers and their clients. It will also help to understand the process of submitting and managing DMFs, fee payments, and facility identification.
Areas Covered in the Session:
  • What is a DMF?
  • DMF held by a Vendor
  • Types of DMF
  • Who needs to file a DMF?
  • eDMFs
  • Best practices for the Letters of Authorization (LOA)
  • Do’s and Don’ts for creating the DMF​
Who will benefit:
  • Active pharmaceutical ingredient (API) manufacturers
  • Contract manufacturing organizations (CMOs)
  • Regulatory Affairs Personnel 
  • Suppliers and distributors of drugs and biologics
  • US Agents
Date: September 1, 2021
​Duration: ​60 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations, USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com