Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes) Training Course :

<strong>Course Schedule - June 8-10, 2009</strong><br/><br/>This course will provide a basic understanding of the FDA Scaleup and Post Approval Changes Guidelines & the recent 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/scaledown, 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:<ol><li> The criteria that determines the level or degree of change.</li> <li>The type of study data or information that must be generated to support changes at each level.</li> <li>The FDA recommended chemistry manufacturing & control tests to support each level or degree of change.</li> <li>The type of in-vivo or in-vitro testing required to support the various levels of degrees of change.</li></ol> 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.