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CGMPs for Pharmaceutical Life Cycle Management

  December 22, 2015  
CfPA-The Center for Professional Advancement, New Brunswick, NJ
May 2-4, 2016

Who Should Attend?
This practical course is intended for professionals in the pharmaceutical, biotechnology, dietary supplements, cosmetic and related industries, including:

  • Supervisory and training staff
  • Management level staff – all departments
  • Investigation Writers and reviewers
  • Validation staff
  • Internal auditors (site and corporate)

It is most beneficial to manufacturing personnel involved in:
  • Manufacturing operations including packaging and the
  • Writing validation documents (including Master Plans)

Higher level technical and managerial personnel will find the course a worthwhile overview of the basics based on new FDA guidance effective 2011.

RAPS - Regulatory Affairs Professional Society 
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's recertification of their Regulatory Affairs Certification (RAC) upon full completion.

Course Description
This course will provide an orientation and understanding of the USA FDA’s Current Good Manufacturing Practice for pharmaceutical product. The course will cover techniques and practices to ensure compliance with these regulations including manufacturing, packaging, holding, distribution and the laboratory. It will provide a practical application of the cGMP on the operating level. Actual experiences and case studies will be included. Ample time will be given to the specific problems of participants. This course will prepare first-line supervisors and will provide an update to managerial level staff to successfully discharge their responsibility for implementing a firm’s QMS.
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
Dr. Mary Foster; Life Science Industry Regulatory Compliance Expert

Mary Foster, PharmD, Life Science Industry Regulatory Compliance Expert worked for Aphena Pharma Solutions as the corporate VP Quality and Regulatory Affairs. Previously, she was the VP Quality for Catalent. Dr. Foster is a regulatory/quality professional with 30 years' of experience in human pharmaceutical /biotechnology, veterinary and OTC monograph products, dietary supplements/nutraceuticals/ foods; medical devices and cosmetics. She has also been responsible for regulatory filings (ANDA's) and regulatory affair's processes.

Dr. Foster has expertise in USA FDA drug cGMP and device Quality System development and implementation, experience with Canadian, South American countries and EU cGMP and interface with Australia and Japan in development of compliance programs. Subject matter expert in creating and maintaining compliant regulatory USA DEA environment, Dr. Foster has been responsible for creation of Quality Management System development for new company formed from divestiture and, responsible for developing.

Dr. Foster is the Chair of United States Pharmacopeia (USP) 2010-2015 Expert Committee on Packaging, Storage and Distribution of drug product. She holds BS in pharmacy and PharmD degrees from the University of Kentucky and BFA from Western Kentucky University.r Catalent Pharma Solutions (formerly Cardinal Health, PTS).


Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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