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

This DMFs (Drug Master File) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted. 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 , present strategies for establishing and maintaining effective change control programs , along with facilitating effective communications with regulatory agencies and your own customers and vendors.

Why You Should Attend:

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

Areas Covered in the Session :

• 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.

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Validation Professionals
• Development and Preparation of Submission Materials

Course Director: CHARLES H. PAUL 

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.