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The Center for Professional Advancement, New Brunswick, NJ
June 9-11, 2008
Who Should Attend
This course is intended for personnel in the pharmaceutical industry involved in the development of drug dosage forms including:- Process Development
- Technical Service
- Pilot Plant
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Production
It will also be of value to personnel wanting a comprehensive understanding of FDA guidelines and requirements relevant to changes in formulation, equipment and process in the following fields:- Analytical Services
- Product Development
- Production
- Quality Assurance
- Project Management
Description
This course will provide a basic understanding of the FDA Scaleup and Post Approval Changes Guidelines & the recent 2004 guideline on Changes to approved NDA or ANDA. This also addresses the impact of withdrawal of the FDA BACPAC I guideline on changes in API synthesis. The issues affecting batch size scaleup/scale-down, various post approval formulation component or composition changes, site of manufacturing changes, manufacturing process changes, and/or equipment changes will be addressed along with the issues affecting analytical methodology, packaging and labeling changes.
The course will focus on:- The criteria that determines the level or degree of change.
- The type of study data or information that must be generated to support changes at each level.
- The FDA recommended chemistry manufacturing & control tests to support each level or degree of change.
- The type of in-vivo or in-vitro testing required to support the various levels of degrees of change.
Case examples will be employed to allow the students to determine the type of data that are required to support the level of changes proposed.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Mukund “Mike” Yelvigi; Director and Head of CMC Therapeutic Area Management Chemical and Pharmaceutical Development Division, Wyeth Research Laboratories
Mukund "Mike" Yelvigi is currently Director and Head of CMC Therapeutic Area Management function in Chemical Pharmaceutical Development Division of Wyeth Research at Pearl River, New York. He has 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 twenty 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. He has earlier worked at other companies such as 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 is Chairperson of the AAPS Manufacturing/Engineering & Quality (MEQ) Focus Group and is also an Executive committee member of the Industrial Pharmacy Section of FIP.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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