Meeting your Regulatory and Processing Responsibilities

Overview:

This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers 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 lies 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.

Areas Covered In the Session:

• 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

Who Will Benefit: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

Speaker Profile
Robert J. Russell For the past 9 years, He 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.