Biopharmaceutical & Pharmaceutical Training & Technology, Medical Device & Biotech Training - CfPIE
email this pagequestions or commentsemail listview cart
header image header image

Courses by Type

Courses by Date

Courses by Location

Certification Programs

Client Endorsements

On-Site Training

Course Catalog

Course Locations
& Transportation


Accreditation

About Us

Press Releases

Frequently Asked
Questions


Employment
Opportunities


Suggest a Course

Site Map




Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities




Who Should Attend


This course was developed for those involved in the manufacture of pharmaceutical and biologic products, components, and packaging materials.  The course will be especially useful for personnel responsible for:
  • Manufacturing
  • Regulatory Affairs
  • Research and Development
  • Quality Assurance & Control
  • Development and Preparation of Submission Materials

In addition, anyone involved in areas of production or validation will find this course useful.

The course will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel.



Learning Objectives

Upon completion of this course, attendees will 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.  The course will also emphasize the "organic" nature of DMFs and present strategies for establishing and maintaining effective change control programs and facilitating communications with regulatory agencies and your own customers and vendors.



Course Description

This course provides attendees with an understanding of the role DMFs play in the FDA's regulatory approval process for drugs and biologics.  The course will take participants through a step-by-step process of DMF preparation and explain the types of information essential for any Drug Master File.  Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.
 

The course offers methodologies and techniques on:

  • Who really needs a DMF and why
  • The various types of DMFs - which is best for your products
  • The relationship between DMFs and drug and biologics applications
  • The symbiotic relationship between DMFs and current Good Manufacturing Practices (cGMPs)
  • Common DMF errors - how to avoid them
  • How to deal with deficiency letters and their origins
  • Effective change control strategies
  • Ramifications of inadequate preparation and/or maintenance and recent enforcement actions and inspectional trends 



arrowView Course Agenda



Past Participants' Comments:

"This is one of the few courses on the subject of DMFs from which I got useful, definitive information.  After most other courses, I wish I hadn’t gone at all because of the work I wasn't getting to.  This time, it was well worth it."
Dustin S., Sr. Regulatory Affairs Associate, Noramco

"The workshop at the end of the course was very good & inclusive.  A true joy."
Therodore R.,  Associate Clinical Manager, Astellas Pharma

"Best training course I’ve ever attended! Small classroom approach allows for more dialogue with colleagues.  The instructor asked about everyone’s background witch enabled him to tailor content to the audience's needs."
Christina R., Regulatory Affairs, Kerry Bio-Science

"Excellent instructor! Encouraged questions and answered them clearly. Small class allowed for effective Q&A."
Teresa M., Regulatory Manager-Pharma, Kerry Bio-Science

"The Course Director's presentation was clear and interesting. His interaction with the group was stimulating and responses to questions were well thought out and on target. A terrific presentation."
Peter S., Associate Director, Genzyme

"The course was absolutely perfect!  It was especially nice that the Course Director knew about both EU and US regulations."
Christine O., Regulatory Associate, Novo Nordisk

"The Course Director did an excellent job in presenting and discussing the subject of DMF. This course and the Course Director have both exceeded my expectations."
Farid S., Director, Quality, Winpak Packaging

"I am very happy with the DMF course material and related discussion.  This course has given me added confidence to successfully approach a Drug Master File.  To aid development of my knowledge, I intend on seeking additional training from CfPIE to develop my R.A. credentials."
Annie Y., RA Manager, Tech Group Europe

"This course and director really made the entire process so much clearer.  Well worth the investment!"
Anita N., Quality Coordinator – Regulatory Group, Mallinckrodt Baker, Inc.

“I found this class to be extremely informative.  I came into this training knowing only how to archive this type of document.  This course has broadened my knowledge of what a DMF is and the reason for these types of documents. I am very excited to go back to my office and review the DMFs we currently have in our archives."
Priscilla D., Document Coordinator, Otsuka America

"The Course Director presented the material in a clear and concise manner.  His use of examples that everyone can relate to makes the material much more clear and more poignant.  In addition, the setting and amenities of the facility added to the comfort and ease of the program...kudos!"
Charlie, Vice President, CSCS

Please Select a Location / Date Before clicking on the Register Button:

Certification Programs available for this Course:
Global Regulatory Affairs Compliance Professional (GRACP)

Related Courses:
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
Preparing the CMC Section for NDAs/INDs/CTDs
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA



Courses by Type I Courses by Date I Courses by Location I Certification Programs I Client Endorsements
On-Site Training I Course Catalog I Course Locations & Transportation I Accreditation I About Us
Press Releases I FAQs I Employment Opportunities I Site Map I Cancellation Policy

The Center for Professional Innovation & Education®
7 Great Valley Parkway, Suite 128
Malvern, PA 19355
Phone: 610-688-1708