Pharmaceutical Process Development
November 30 - December 02, 2009
Amsterdam, The Netherlands
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is intended for personnel in process development, technical service and pilot plant groups within the pharmaceutical industry. This includes personnel responsible for manufacturing of dosage forms for clinical studies. It will also be of value to personnel in:
• Research & Development
• Product Development
• Production
• Regulatory Affairs
• Analytical Services
• Manufacturing
• Quality Assurance
• CMC Projects
The course is not designed to provide an in-depth review of science and technology of any specific process technology. Other courses offered by CfPA should be considered for that purpose.
Description
This three-day course is designed to provide a basic understanding of the significant process development effort involved in taking an R&D laboratory formulation to commercial production. This course will focus on two main areas:
1. How to develop a pilot process suitable for scale-up to commercial production.
2. Factors to consider during scale-up and technology transfer to take a product from formulation development to the production floor.
The course will review topics such as process flow and equipment selection. Regulatory considerations, such as documentation and a need for pilot scale products to be representative of commercial production, will be discussed.
Various technologies available for manufacturing dosage forms will be reviewed in the context of scale-up parameters. These will include processing methods for mixing, granulation, compression and coating of solid dosage forms, as well as processing methods for solutions, emulsions, suspensions and sterile parenteral products.
Other Courses of Interest
Biopharmaceutical Process Systems
CMC Submissions in CTD Format
Apr 26 2010, New Brunswick, NJ
IQ, OQ, PQ
May 25 2010, New Brunswick, NJ
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
Real World Approaches to PAT and QbD Implementation
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Apr 26 2010, Amsterdam, The Netherlands
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Jun 07 2010, New Brunswick, NJ
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