One-Day Virtual Seminar

The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities

BY: Robert J. Russell, President and CEO, RJR Consulting, Inc.

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

Coming soon.. Please contact customer care for new schedule
  • Course Description
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This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

The course will include 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, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.

The conversion of paper to e-filings requirements with FDA will also be discussed. The process used for e-filings will be reviewed in detail. Maintaining filings for Annual Reports and DMF Amendments will also be covered.

Upon completion of this course, attendees will understand how to prepare Quality Agreements, Drug Master Files (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 the 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 along with customers and vendors.

The course will also discuss the movement by U.S. FDA to convert from a paper filing system to electronic submissions for initial DMF submissions, annual updates and DMF amendments.

Why You should Attend:

This course provides attendees with an understanding of the role that Quality Agreements and 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 when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement. The DMF section will explain content, format, preparation and the types of Drug Master Files which can filed in the U.S., as well as the EU, Japan and Canada. 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:

The course offers methodologies and techniques on:
Quality Agreements

  • The Origin and Background around Quality Agreements
  • When are Quality agreements appropriate?
  • The Scope of Quality Agreements
  • Quality Agreement Formatting and Content
  • How to negotiate a Quality agreement
DMFs
  • 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 (c-GMPs).
  • 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 inspection trends.
  • The conversion from paper to e-filings at FDA for Human and Veterinary Products.
Who will Benefit:

This course is developed for those involved in the manufacture of Pharmaceutical, Biologic and Medical Device products, components, and packaging materials. The course will be especially useful for personnel responsible for:

  • Manufacturing
  • Regulatory Affairs
  • Project Managers
  • Global Supply Chain
  • Research and Development
  • Quality Assurance & Control
  • Validation
  • Development and Preparation of Submission Materials
  • General Management
Day 01(10:00 AM - 4:00 PM PDT)
  • Introduction (15 mins)
  • Quality Agreements
    • The Origin and Background around Quality Agreements
    • When are Quality agreements appropriate?
    • The Scope of Quality Agreements
    • Quality Agreement Formatting and Content
    • How to negotiate a Quality agreement
  • What are DMFs?
    • Types of DMFs (Types II, III, IV and V)
  • The rationale and preparation process for DMFs
    • Why DMFs are important to you and your company
    • How DMFs fit into FDA's regulatory processes for review of drug and biologic applications
    • Why, more than ever, you may need DMFs to maintain current supplier agreements as well as to develop new business relationships
    • What not to include
  • DMF Preparation: What you need and why you need it
    • The essential components of all DMFs, including:
    • The relationship between DMFs and c-GMPs
    • Tactics for avoiding the most common DMF-related errors
    • Tactics for dealing with unique or novel situations/unfavorable reviews
  • FDA Review: How FDA reviews DMFs and why.
    • What you should expect throughout the DMF preparation and filing process
    • How to communicate and work with FDA to ensure success
  • Components Associated with a DMF:
    • DMF vs. Application
    • Acknowledgement Letter
    • Letter of Authorization
    • Changes to a DMF
    • Annual updates
    • Obligations of a DMF holder
    • Transmissions - transmittal letter
    • Deficiency letter
    • Auditing Vendor
    • Inside tips
    • Changes to DMF system in last 10 years
    • Binder specifications and cover sample
  • Japan DMFs
  • European DMFs
  • Canadian DMFs
  • Change control and maintenance: Why accurately maintaining your DMFs is important
    • DMFs as "living" documents. DMF updates and amendments
    • Types of DMF-related changes that impact drug/biologic applications: production facilities, composite materials, manufacturing processes
    • What you must report and to whom - the importance of establishing communication pathways with regulatory agencies, customers and vendors
Robert J. Russell
Robert J. Russell, President and CEO, RJR Consulting, Inc

Robert J. Russell (Bob) is President / CEO of RJR Consulting, Inc. which specializes in helping clients navigate through Global Regulatory Compliance requirements for Pharmaceuticals, Medical Devices, Biologics, Combination Products and Dietary Supplement / OTC products. Prior to founding the company 19 years ago, Bob had more than 27 years of experience in CMC, Global Business development and Regulatory Affairs for two Fortune 200 firms developing innovative Pharmaceuticals and Medical Devices.

Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization / registration preparation, meet variations / amendment filing responsibilities and license renewal filings. He has practical experience counseling Pharmaceutical and Device manufacturers through GMP, GCP, GLP requirements, CE marking / ISO certifications, Drug / Device Master File preparation, mock pre-audits and issues management with Global Healthcare Authorities. Bob is a past member of the International GMP Working Group on Standards for Industry harmonization with several colleagues from Europe. He holds a B.S. And M.S. in Chemistry.

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