Course offering number:1204-404
Course ID:
1358
Pharmaceutical Process Development
23-25 April 2012
Amsterdam, The Netherlands
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
• Analytical Services
• Product Development
• Manufacturing
• Production
• Quality Assurance
• Regulatory Affairs
• 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:
- How to develop a pilot process suitable for scale-up to
commercial production.
- 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
Sep 10 2012, Burlingame, CA
CMC Submissions in CTD Format
Oct 08 2012, Amsterdam, The Netherlands
IQ, OQ, PQ
Oct 30 2012, New Brunswick, NJ
Pharmaceutical Technology Transfer
Jun 13 2012, Amsterdam, The Netherlands
Pilot Plant and Scale-up Studies
Aug 27 2012, New Brunswick, NJ
Process Plant Start-Up
Real World Approaches to PAT and QbD Implementation
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
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