Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
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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 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:
- The criteria that determines the level or degree of change.
- The type of study data or information that must be generated
to support changes at each level.
- The FDA recommended chemistry manufacturing & control
tests to support each level or degree of change.
- 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.
Other Courses of Interest
CMC Submissions in CTD Format
Apr 26 2010, New Brunswick, NJ
Biopharmaceutical Process Systems
Generic Drug Approvals
May 03 2010, New Brunswick, NJ
INDs/NDAs/CTDs
Mar 22 2010, Burlingame, CA
Pharmaceutical Process Development
Pharmaceutical Technology Transfer
Apr 28 2010, Amsterdam, The Netherlands
Pilot Plant and Scale-up Studies
May 10 2010, Amsterdam, The Netherlands
Process Plant Start-Up
Apr 19 2010, Amsterdam, The Netherlands
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