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CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
11-13 June 2012
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 Scale-up and Post Approval Changes Guidelines & the 2004 FDA 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 and European variation guidelines. 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/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 & European 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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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Mukund “Mike” Yelvigi; Independent Pharmaceutical Consultant, Adj. Assoc. Professor of Pharmacy, School of Pharmacy, University of Mississippi
Mukund "Mike" Yelvigi is an Independent Pharmaceutical Consultant. He retired from Pfizer Inc in 2012, as Director of Logistics in Supply Chain Management at Pfizer Inc, Earlier he was Sr.Director and Head of CMC Portfolio Management function in Wyeth Inc. New York. He was 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. Prior to this, he was Head of Process Development and clinical supply group at Hoffman-La Roche Company, New Jersey. He has 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 was Chairperson of the AAPS Manufacturing Science & Engineering Section (MSE) 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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sberg@cfpa.com
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