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

 
  January 14, 2010  
     
 
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
26-28 April 2010


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 guidelines 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 scale-up/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.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Mukund "Mike" Yelvigi; Director, Development Planning Chemical and Pharmaceutical Development Wyeth Research Laboratories
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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