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

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Jul 07, 2016
90 minutes
Product Description

Stay Compliant with DMF by Understanding Current Enforcement and Review Climate

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.

Learning Objectives

  • The role played by DMFs in the FDA approval process for drugs and biologics;
  • Step-by-step guidance on DMF preparation;
  • Types of information required for any drug master file;
  • Why “on-size-fit-all” doesn’t work;
  • Importance of customizing DMFs to prepare and maintain them for particular businesses and products;
  • Common DMF errors and how to avoid them;
  • How to deal with deficiency letters and their origins;
  • Effective change control strategies and ramifications of inadequate preparation; and
  • Maintenance and recent enforcement actions and inspectional trends.

Session Highlights:

  • What are DMFs?
  • Who actually needs a DMF?
  • Relationship between DMFs and drug and biologics applications
  • Symbiotic relationships between DMFs and current Good Manufacturing Practices (cGMP)
  • The rationale and preparation process for DMFs.
  • Linkage of DMFs to Quality Agreements
  • DMF Preparation: What you need and why you need it.
  • FDA Review: How FDA reviews DMFs and why.
  • Components Associated with a DMF:
  • Japan DMFs
  • European DMFs
  • Canadian DMFs
  • Change control and maintenance: Why accurately maintaining your DMFs is important.

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:

  • Manufacturing
  • Regulatory Affairs
  • Research and Development
  • Quality Assurance & Control
  • Validation
  • Development and Preparation of Submission Materials

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Robert J. Russell

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.

Today, Robert assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations...   More Info
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