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Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)

  January 13, 2014  
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
2-4 June 2014

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

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:

  1. The criteria that determines the level or degree of change.
  2. The type of study data or information that must be generated to support changes at each level.
  3. The FDA & European recommended chemistry manufacturing & control tests to support each level or degree of change.
  4. 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.
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Mukund “Mike” Yelvigi; Founder and Principal, Center for Pharmaceutical Integration, LLC. New Jersey

Mike Yelvigi is founder & principal 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.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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