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2600 E. Bayshore Road
Palo Alto, CA 94303
(888) 717-2436

Event Description

This DMFs (Drug Master Files) 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.

Why Should You 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.

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 , present strategies for establishing and maintaining effective change control programs , along with facilitating effective communications with regulatory agencies and your own customers and vendors.

Who Will Benefit:
This course is 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:
Regulatory Affairs
Research and Development
Quality Assurance & Control
Development and Preparation of Submission Materials

Instructor Profile:
For the past 9 years, Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

Not sure if you want to exhibit at or attend the Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities? See the panels below to get the information you need to make an informed decision.

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Event Details

Conference/Event Dates: 08/17/2016 - 08/17/2016
Conference/Event Hours: 10:00 AM to 11:30 AM
Classification: B2B
Primary Industry: Sciences
Other Industries: Business, Sciences
Audience: Manufacturing
Regulatory Affairs
Research and Development
Quality Assurance & Control
Development and Preparation of Submission Materials
Show Owner:ComplianceOnline

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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