Course Description

Pharmaceutical Technology Transfer and Post-Approval Changes

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Course ID 2671

In-Person Course

Who Should Attend?
This course is currently not scheduled. We do have our NEW course available:
Pharmaceutical Technology Transfer and Regulatory Strategies

This course is intended for individuals from:
  • Formulation and Process Development/Validation
  • Regulatory Affairs, QA, QC
  • Analytical Methods Development
  • Package Development/Engineering
  • Manufacturing and Technical Support
  • Project Management and Planning

Participants will benefit by gaining a better understanding of the complexities of technology transfer of various dosage forms in the pharmaceutical industry.

Course Description
This 3-day intensive, accredited course will provide a basic understanding of the technology transfer of analytical methods, quality control standards, packaging components/operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an understanding of the issues affecting the transfer within and outside a company. Topics will include transfer of technology to/from international sites as well as to/from third parties. This course will also provide an understanding of the FDA Scale-up and Post Approval Changes Guidelines & the 2004 FDA guideline on changes to an approved NDA or ANDA. The issues affecting batch size scale-up/scale-down, various post approval formulation component or composition changes, site of manufacturing changes, manufacturing process changes, and equipment changes will be addressed along with the issues affecting analytical methodology, packaging and labeling changes. Speakers will use practical examples to highlight issues critical to successful technology transfer in compliance with FDA regulations.

Interactive case studies based on real examples will allow participants to develop strategies and plans in a team environment.

Course Director
Walter G. Chambliss, Ph.D., Professor and Research Professor Emeritus, Pharmaceutics and Drug Delivery, University of Mississippi

Walter G. Chambliss, Ph.D. is Professor Emeritus of Pharmaceutics and Drug Delivery, and Research Professor Emeritus in the Research Institute of Pharmaceutical Sciences at the University of Mississippi. He teaches graduate courses in pharmaceutical formulation development, manufacturing and regulatory sciences. He also lectures in the Hands-on Course in Tablet Technology (, a post-graduate education course. In addition to teaching he managed the technology transfer operations of the university for 20 years. Dr. Chambliss received a B.S. in Pharmacy, a M.S. in Pharmaceutics and a Ph.D. in Pharmaceutics from the University of Mississippi. He worked for 17 years in research and development in the pharmaceutical industry at G.D. Searle, Bristol-Myers and Schering-Plough where he was Vice President of R&D for the HealthCare Products Division. He has extensive experience in formulation development and process development of a wide variety of dosage forms. Dr. Chambliss is a Fellow of the American Pharmaceutical Association and a past-President of the Academy of Research and Science. He has authored or co-authored over twenty publications including three book chapters in pharmaceutical reference books.

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Course Director
Mukund “Mike” Yelvigi; Principal and Managing Partner, Center for Pharmaceutical Integration, LLC. New Jersey

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. Earlier to this, he was Head of Process Development and clinical supply group at Hoffman-La Roche Company, New Jersey. Other companies he has worked include 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.

He is an adjunct Assistant 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 a editorial board member of Pharma Times journal.

Additional Faculty
Michael J. Valazza, Vice President of Business Development, Catalent Pharma Solutions

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