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CfPA-The Center for Professional Advancement, Burlingame, CA
July 20-22, 2015
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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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| Mukund "Mike" Yelvigi; Founder and Principal, Center for Pharmaceutical Integration, LLC. New Jersey |
Mike Yelvigi, Founder and Principal at Center for Pharmaceutical Integration LLC, provides consultation service to the industry in the area of CMC support & Technology Integration and Transfers. Former Sr. Director and Head of CMC Therapeutic Area at Pfizer/Wyeth Inc., Mr. Yelvigi 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. Previously, he was Head of Process Development and clinical supply group at Hoffman-La Roche and has also worked with 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.
Mr. Yelvigi is an adjunct Associate 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 an editorial board member of Pharma Times journal.
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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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sberg@cfpa.com
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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.