CfPA-The Center for Professional Advancement, Edison, NJ or Virtually
April 20-21, 2020
Who Should Attend?
This course is intended for individuals from:
• Innovator, Generic, CMO, CRO and CDMO Companies
• Formulation and Process Development/Validation
• Regulatory Affairs, Quality Assurance
• Analytical Methods Development/Quality Control
• Package Development/Package Engineering
• Manufacturing and Technical Support
• Project Management and Operations Planning
Participants, as well as their managers, will benefit by gaining a better understanding of the complexities of technology transfer in the pharmaceutical industry. The course covers transfers of small molecule drug products; not biotechnology, vaccines or medical device products. Course Description
|
|
|
Invited Speakers:
|
|
 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 (tabcourse.com), 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.
 Mukund “Mike” Yelvigi, Principal & 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.
|
|