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When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
Formulation Scale-Up of Solid, Semi-Solid, Liquid & Sterile dosage Forms, Quality by Design, Clinical Supply Manufacture, and Regulatory Considerations
This 12-hour accredited 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.
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.
Can’t Make the LIVE Course dates?
You can register now for the on demand! Simply select the On Demand option when registering and we will automatically send you access to the recorded version for you to view for 30 days. On Demand will be available within 2 weeks after the live offering.
PLEASE NOTE:Since this training is highly interactive, you must have a webcam on your computer equipped with a microphone and speakers/headset in order to fully participate.
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
– Production
– Analytical Services
– Quality Assurance
– Product Development
– Regulatory Affairs
– Manufacturing
– CMC Projects
Mukund Mike Yelvigi
Principal and Managing Partner, Center for Pharmaceutical Integration, LLC. New Jersey
Mukund (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. 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.