COURSE ID 2904

Pharmaceutical Technology Transfer and Regulatory Strategies

AVAILABLE On-demand
12 Hours

On-Demand

Offering Price
$ 2150
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Team Training

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.

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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.

This 12-hour accredited ON DEMAND course, will provide a basic understanding of the technology transfer of analytical methods, active pharmaceutical ingredients, 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 transfers within and outside a company. Topics will include transfers to/from international sites as well as to/from third parties.

This intensive course will also provide an overview of relevant FDA and ICH regulatory guidance documents including the Scaleup and Post Approval Changes (SUPAC) guidance documents and the Changes to an Approved NDA or ANDA Guidance. The issues affecting changes to the batch size, formulation, packaging components, site of manufacture, manufacturing process, analytical methods, specifications and processing equipment changes will be addressed. Speakers will use practical examples to highlight issues critical to successful technology transfer.

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

– 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 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.