CfPA-The Center for Professional Advancement, New Brunswick, NJ
June 6-8, 2017
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. Course Description
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Invited Speakers:
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| Course Director |  | Mukund “Mike” Yelvigi; Principal and Managing Partner, Center for Pharmaceutical Integration, LLC. New Jersey |
Mike Yelvigi is Principal and Managing Partner at Center for Pharmaceutical Integration LLC, which provides consultation service to the industry in the area of CMC support &Technology Integration and Transfers (mergers & acquisitions). He retired as Sr. Director and Head of CMC Therapeutic Area Management function at Pfizer/Wyeth Inc. NY. He had responsibility for co-ordination of CMC activities related to drug substance synthesis, drug product formulation, analytical development and regulatory filing for several therapeutic areas. He has over thirty years extensive experience in pharmaceutical formulation, process development/scale-up, process validation, manufacturing and pre-approval inspections and has successfully launched several products globally. Earlier to this, he was Head of Process Development and clinical supply group at Hoffman-La Roche Company, New Jersey. Other companies he has worked include Parke Davis (USA), G.D Searle and Organon Inc. He obtained his undergraduate degree in Pharmacy from Bombay University and graduate degree in Pharmacy, from Philadelphia College of Pharmacy.
He is an adjunct Assistant Professor of Pharmaceutics at the School of Pharmacy, University of Mississippi. He is an active member of AAPS, ISPE, AAiPS, FIP and has lectured at many symposiums in the pharmaceutical technology, drug development areas. He was the Chairperson of the AAPS Manufacturing Science & Engineering section and is also an Executive committee member of the Industrial Pharmacy Section of FIP. He is a editorial board member of Pharma Times journal.
Additional Faculty
Jay Rheingold, Founder, Drug Product Solutions, LLC
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- 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.