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Pharmaceutical Process Development

  December 15, 2015  
CfPA-The Center for Professional Advancement, New Brunswick, NJ
June 28-30, 2016

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
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.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Mukund “Mike” Yelvigi; Founder and Principal, Center for Pharmaceutical Integration, LLC. New Jersey

Mukund (Mike) Yelvigi is founder & principal 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. He obtained his undergraduate degree in Pharmacy from Bombay University and graduate degree from Philadelphia College of Pharmacy.

He is an adjunct Assistant Professor of Pharmaceutics at the School of Pharmacy, University of Mississippi and an active member of AAPS, ISPE, AAiPS, FIP. 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.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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