The Center for Professional Advancement, New Brunswick, NJ
July 23-25, 2007
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 inResearch & 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: 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.
Course Type: A Three Day Intensive Course
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