The Center for Professional Advancement, Amsterdam
3-5 December 2007
Who Should Attend:
This course is intended for personnel in the pharmaceutical industry involved in the development of drug dosage forms including:Process Development
Technical Service
Pilot Plant
Quality Assurance
Regulatory Affairs
Research & Development
Production It will also be of value to personnel wanting a comprehensive understanding of FDA guidelines and requirements relevant to changes in formulation, equipment and process in the following fields: Analytical Services
Product development
Production
Quality Assurance
Project Management
Description:
This course will provide a basic understanding of the FDA Scaleup and Post Approval Changes Guidelines & the recent 2004 guideline on Changes to approved NDA or ANDA. This also addresses the impact of withdrawal of the FDA BACPAC I guideline on changes in API synthesis. The issues affecting batch size scaleup/ scale-down, various post approval formulation component or composition changes, site of manufacturing changes, manufacturing process changes, and/or equipment changes will be addressed along with the issues affecting analytical methodology, packaging and labeling changes. The course will focus on: 1. The criteria that determines the level or degree of change.
2. The type of study data or information that must be generated to support changes at each level.
3. The FDA recommended chemistry manufacturing & control tests to support each level or degree of change.
4. The type of in-vivo or in-vitro testing required to support the various levels of degrees of change. Case examples will be employed to allow the students to determine the type of data that are required to support the level of changes proposed.
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