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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. 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.

Course Audience:
  • Manufacturing
  • Regulatory Affairs
  • Project Managers
  • Global Supply Chain
  • Research and Development
  • Quality Assurance & Control
  • Validation
  • Development and Preparation of Submission Materials
  • General Management

Day 1 Schedule Lecture 1: 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 Lecture 2: What are DMFs? Types of DMFs (Types II, III, IV and V) Lecture 3: 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 Lecture 4: DMF Preparation: What you need and why you need it The essential components of all DMFs, including: The relationship between DMFs and cGMPs Tactics for avoiding the most common DMF-related errors Tactics for dealing with unique or novel situations/unfavorable reviews Day 2 Schedule Lecture 1: 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 Lecture 2: 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 Lecture 3: 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

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