Nancy Duarte-Lonnroth
Instructor Nancy Duarte-Lonnroth
Product Id 600169
Duration 60 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

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


This course provides attendees with a basic understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics.

The course will overview the process of DMF preparation and explain the types of information essential for any Drug Master File. Additionally, this course will explain the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.

Understand how to prepare and file DMFs with the FDA and the rationale behind doing so. Participants will gain practical knowledge about what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and strategies for avoiding the most common DMF-related errors.

Areas Covered in the Session:

  • Definitions
  • Who really needs a DMF and why
  • US DMF: types and content.
  • Submissions to Drug Master Files
  • Drug Master File Contents
  • Format, Assembly and Delivery
  • Authorization to Refer to a DMF
  • DMF Holder and Transfer Obligations

Who Will Benefit: The course is addressed to personnel in the areas of the company involved in the preparation of regulatory documentation personnel from Regulatory Affairs, Quality Assurance, Quality Control, R&D, and, in general, all personnel with responsibilities in the preparation and maintenance formal documentation of products.  The course will be especially useful for personnel responsible for:

  • Managers, technical staff for QA and QC, and regulatory affair personnel for API companies
  • Technical staff for QA and QC, and regulatory affair personnel for packaging material, excipient, colorant, flavor essence companies

Speaker Profile
Nancy, is the Director of Quality & Regulatory Affairs, Healthcare responsible for global coordination of Celestica's Healthcare Quality, Regulatory and FDA compliance. Nancy is Quality and Regulatory expert with fifteen years experience in regulatory affairs, quality systems, compliance, clinical quality, validation, auditing, quality control, data management systems, post market surveillance, supplier management and regulatory compliance in the areas of bio/pharmaceuticals, medical devices and combination products. Nancy has contributed to the success of both venture and public companies, establishing a track record of successfully achieving timely global regulatory approvals, initiating and effectively managing preclinical and clinical investigations and developing and maintaining effective and compliant quality systems in various healthcare sectors.

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