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The Center for Professional Advancement, Amsterdam, The Netherlands
14-16 April 2008
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:
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.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Mukund (Mike) Yelvigi; Director, CMC Development Planning; Wyeth Research Laboratories
Mukund “Mike” Yelvigi is a Director of Development Planning, Chemical & Pharmaceutical Development at Wyeth Research Laboratories at Pearl River, New York. Mr. Yelvigi has the responsibility of coordination of activities related to drug substance synthesis, drug product formulation, analytical development and regulatory filing for anti-inflammatory therapeutic area. He has over twenty years of extensive experience in pharmaceutical formulation, process development/scale-up, process validation and pre-approval inspections and has successfully launched several products into market. Previously, Mr. Yelvigi was Head of Process Development at Hoffman-La Roche Company, New Jersey. His area of expertise is solid/liquid/parenteral dosage form scale-up/process validation and product launch. He also held the position of Manager of Clinical Manufacturing Group at Hoffman-La Roche. He has extensive experience in technology transfer of dosage forms in USA/Europe and Japan. He has earlier worked at other companies such as Parke Davis, Organon Inc., Ranabaxy Ltd. India.
Mr. Yelvigi is an active member of AAPS, FIP, ISPE, Chair, Manufacturing, Engineering, Quality Focus Group, AAiPS and has lectured and chaired many symposiums in the pharmaceutical technology/ CMC project management areas.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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