| |
|
|
|
CfPA-The Center for Professional Advancement, Edison, NJ or Virtually
April 6-7, 2020
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 Course Description
|
|
|
|
|
|
|
|
Organized by:
|
|
CfPA-The Center for Professional Advancement |
|
|
Invited Speakers:
|
|
 Mukund “Mike” Yelvigi; Principal and Managing Partner, 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.
Additional Faculty
Jay Rheingold, Founder of Drug Product Solutions, LLC, provides consulting on pharmaceutical development and manufacturing activities. Formerly, Dr. Rheingold served as VP, Pharmaceutical Development at Tobira Therapeutics and Barrier Therapeutics. Dr. Rheingold, received his B.S. in Biology from the State University of New York and his M.S. and Ph.D. in Pharmaceutical Sciences from the University of Connecticut.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
N/A
|
|
|
|
|
|
|
|
Registration:
|
|
Please click here for registration information.
|
|
|
E-mail:
|
|
Jmorbit@cfpa.com
|
|
|
|
|
|
|
|
|
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.
This training is ideal for those new to this area but will also benefit those who are experiencing problems with existing development or process activities.