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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 Participant's Comments

"Of all the training and miscellaneous clinics I've been to, this was by far the most fluid and informational.  And I didn't look at my watch every ten minutes."
Shannon D., Human Resources Generalist, International Converter, Inc.
 
"Very informative!  Had the most up-to-date information available.  This is the best class I've attended in many years."
Kathy L., Quality Assurance Manager, AMCOL Health
 
"This course was very informative and information was clearly and thoroughly explained.  Well worth the trip!  I really enjoyed the way the audience was encouraged to participate and think for themselves.  I have taken a lot away from this course."
Rebecca B., Technical Manager, AQUI-S New Zealand Limited
 
“I thoroughly enjoyed this course.  I would highly encourage this course to others and I would like to attend a more advanced class on DMF’s, Type II and V.” 
Heidi S., Senior Vice President, Cody Laboratories, Inc.

“Very knowledgeable and insightful; uses examples very well; very active; makes learning difficult subject matter easy and fun.”
Henry S., Sr. Applications Compliance Specialist, Ciba Specialty Chemicals Corp.

"The presentation format keeps one interested in the subject matter while being entertaining.  This is the first course where I have seen a mass of class participation that was purely voluntary.  I would highly recommend CfPIE courses if they are as well presented as this one.”
Beth S., R&D Manager – Strain Development, Phyton Biotech

“Great course.  I came into this not knowing much but now feel I can discuss DMFs intelligently.  Great job!”
Cynthia E., Principal Technical Consultant, Lancaster Laboratories

“FANTASTIC!  All the information I hoped for.”
Carol G., QA Associate,  Cook Pharmica.

"Active, energetic course director: highly knowledgeable and extremely capable of conveying course information to group.”
Mark S., Clinical Coordinator, Memorial Sloan-Kettering Cancer Center

“The course was very well organized and the instructor did an excellent job of involving the participants.”
Richard G., VP Regulatory Affairs and Drug Enforcement, Cedarburg Pharmaceuticals, Inc.

 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



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