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 thaese 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.
Speaker
Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products. For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries. He holds a BS / MS in Chemistry."
Who Should Attend
- Manufacturing
- Regulatory Affairs
- Project Managers
- Global Supply Chain
- Research and Development
- Quality Assurance & Control
- Validation
- Development and Preparation of Submission Materials
- General Management
