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GMPs In-Depth Analysis for Pharmaceutical Life Cycle Management

  April 24, 2014  
CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
17-19 September 2014

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.

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; Corp VP Quality and Regulatory Affairs, Aphena Pharma Solutions

Dr. Mary Foster is Corporate VP Quality and Regulatory Affairs for Aphena Pharma Solutions. In this role Dr. Foster is responsible for helping to develop and implement the policies and programs to ensure cGMP regulatory compliance. The programs are relative to various regulatory agencies and guidelines. Dr. Foster is the USP Expert Committee Chair for Packaging, Storage and Distribution and a member of the USP Executive Committee. Dr. Foster received her Doctor of Pharmacy and Bachelor of Science degrees from the University of Kentucky. Prior roles include VP Quality, and VP Compliance for 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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