Join this session on DMFs (Drug Master Files) training by expert speaker Robert Russell, to understand and discuss the current enforcement and review climate within FDA, and the manner in which FDA personnel review drug master files (DMFs). DMF, besides being used in US, is also used in the EU, Japan, Canada and Australia, and discussions will also be done on the same. You will come to understand the similarities and differences to the US system.
You will leave this session with an understanding of how to prepare and file DMFs with FDA, and also learn the rationale that works behind it. You’ll gain practical knowledge on how reviewers check on DMFs, and understand the expected consequences which can result due to non-compliance. You will also come to know various strategies that will avoid the commonest DMF-related errors.
Additionally, the presentation will emphasize on DMFs ‘organic’ nature, present strategies which will help in maintenance and establishment of effective change control programs, and facilitate effective communication with regulatory agencies, vendors and customers.
Who Should Attend
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:
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.