Pharmaceutical Process Development
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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
- 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 the Center 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
Pilot Plant and Scale-up Studies
Feb 11 2009, New Brunswick, NJ
Pilot Plant and Scale-up Studies
May 12 2009, Amsterdam, The Netherlands
Process Plant Start-Up
Mar 30 2009, Amsterdam, The Netherlands
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Apr 06 2009, Amsterdam, The Netherlands
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Jun 08 2009, New Brunswick, NJ
Statistical Analysis of Laboratory Data
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