Course: 'Pharmaceutical Technology Transfer and Post-Approval Changes'

This 2-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 FDA guideline on changes to an approved NDA or ANDA. The issues affecting batch size scale-up /scale-down, site of manufacturing changes, manufacturing process changes, and equipment changes will be addressed along with the issues affecting analytical methodology, packaging and labeling changes.

The speaker 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.

Who should attend

This course is intended for professionals from Pharmaceutical Industry involved in:

• Formulation and Process Development/Validation

• Regulatory Affairs, Quality Assurance and Quality Control

• Analytical Methods Development • Package Development/Package Engineering

• Manufacturing and Technical Support

• Project Management and Planning

• Contract Research, Development or Manufacturing Organizations

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

Learning objectives

Upon completion of this course, you will be able to:

- Utilize the interactive processes involved in technology transfer and describe the approaches used to transfer packaging components, analytical methods and dosage forms

- Define the critical issues surrounding technology transfer and how to plan for success

- Use relevant regulatory guidance documents to develop research and regulatory strategies

- List key issues in the selection of third party development and manufacturing partners

Course director:

Mukund (Mike) Yelvigi is founder & principal at Center for Pharmaceutical Integration LLC, which provides consulting 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 at Pfizer/Wyeth Inc. NY. He has over 30 years extensive experience in formulation, process development/scale-up, 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, U of Mississippi and an active member of AAPS, ISPE, AAiPS, FIP. He was the Chairperson of the AAPS Manufacturing Science & Engineering section.

Co-Director:

Walter G. Chambliss, Ph.D., Associate Vice Chancellor for Research and Professor of Pharmaceutics and Drug Delivery at the University of Mississippi.