COURSE ID 2590

Pharmaceutical Semi-Solid Dosage Form: Development, Manufacture & Scale-up

AVAILABLE Live
09/27/2023 - 09/28/2023
8:30am EDT - 4:30pm EDT
12 Hours

Live Online

Early-bird Offer

Limited availability
until September 7, 2023.

$ 2130
Price
$ 2330
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Team Training

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In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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Remember – 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.

For both prescription and OTC pharmaceuticals, a semi-solid dosage form is a very common delivery method for the drug product. But just because they are common does not mean that they are easy to develop and manufacture. In fact, there are a whole host of issues that can arise during development and manufacture that can result in marginal or unacceptable product.

This intensive, 12-hour accredited ON DEMAND course will provide a set of theoretical and practical tools for pharmaceutical semi-solid formulation development either for prescription or OTC drugs. The selection of the correct raw materials and manufacturing processes needed to create stable semi-solid dispersed-phase products and to effectively solve problems arising during development will be addressed. Troubleshooting existing commercial product problems will be emphasized. Emulsion and suspension behavior will be described along with current methods to analyze the behavior of dispersed phases and methods to measure and predict stability. Processing and scaleup issues specific to the type of equipment will be covered. Key emphasis will be placed on application of Quality by Design (QbD) principles and Process Analytical Technology (PAT). Risk analysis tools, key principles of process validation, technology transfers, and clinical manufacturing will be discussed. Chemical engineering aspects of Unit Operations will likewise be addressed.

The course is designed for professionals engaged in the pharmaceutical Semi-Solid dosage forms. It is intended for professionals who work in formulation development, raw materials selection, drug delivery systems, scale-up and manufacturing process, validation, clinical supply manufacture and quality testing. Such personnel include:

– Semi-solid Formulation Scientists

– Manufacturing supervisors/Engineers/Managers

– Manufacturing Operators/Technicians

– Pilot Plant Operation and Scale-Up

– Regulatory Affairs/Quality Control

– CMC Project/Technology Transfer Staff

– R&D scientists/Technicians

– Project Managers/Business Development

course instructor

Mukund Mike Yelvigi
Principal and Managing Partner, Center for Pharmaceutical Integration, LLC. New Jersey

Mukund Mike Yelvigi’s Courses
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.