Drug Master Files — Helping with FDA DMFs
Date: February 27, 2025
Time: 12 PM EST
Duration: 60 Minutes
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).
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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
