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ICH-Q7/Q11

 
  December 05, 2013  
     
 
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
16-17 July 2014


Who Should Attend
This comprehensive course has been designed for individuals whose responsibilities require an understanding of the quality and regulatory aspects of Active Pharmaceutical Ingredient (API) production for both commercial and clinical trial material. Personnel in the following fields should attend:

  • QA/QC 
  • Regulatory Affairs
  • Commercial Production
  • Process Development
  • Pilot-Plant Operations 
  • Auditing
  • Validation
  • Management

Regulatory agency investigators who inspect API operations and facilities are encouraged to attend. Registrants will benefit from individual and group discussion of compliance issues related to worldwide API production in locally regulated environments.

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

Description
It is essential that API production facilities operating under local regulatory authorities in different regions consistently produce the same API that meets the quality attributes and characteristics it is intended to have. An Expert Working Group developed the ICH-Q7 document as a single standard that all suppliers should apply to production of APIs used in human products manufactured in any of the ICH signatory regions. This course also includes sections on APIs produced by cell culture/fermentation and on APIs used in clinical trials.

The course will provide historical insight and specific interpretation of the requirements in the Q7 document along with principles espoused in the draft ICH Q11 document. The Q7 document addresses all aspects of API production in 19 sections and each of these sections will be critically examined in detail during the course. There are also two group discussions to clarify individual issues and exchange information among colleagues. Also included is a workshop in which registrants are asked to apply what they have learned to resolve issues in test cases based on actual FDA-483 observations.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Richard G. Einig, Ph.D., RAC, CQA; Pharmaceutical Quality Assurance Consultant

Richard G. Einig, Ph.D., RAC, CQA is a consultant specializing in the pharmaceutical and veterinary medicine industries. His experience spans over twenty years in senior management of quality, regulatory and development units of large international companies and start-up “biotechs”. He has worked internationally with innovator and generic dosage form companies, medical device manufacturers and research organizations.

Dr. Einig participated in developing the PhRMA Bulk Pharmaceutical Committee's Guidance on Production of Drug Substance, and is an invited speaker at domestic and international meetings on quality and processing of pharmaceutical products.

Dr. Einig is a member of the American Chemical Society as well as a member and carries certifications from the American Society for Quality, the Regulatory Affairs Professional Society, and the Institute for Independent Business. He received undergraduate and graduate degrees in Chemistry from St. Louis University, MBA from Webster University, and PhD from Missouri University.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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