home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
  HUM-MOLGEN -> Events -> Courses and Workshops  

Using ICH Guidelines to Re-enforce Your GMP Compliance

  January 02, 2013  
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
15-17 April 2013

Who Should Attend
This course is designed for those who already have some experience in Good Manufacturing Practice, either in the production of Active Pharmaceutical Ingredients or in the manufacture of Medicinal Products.

Amongst others, the course will benefit:
  • Production technicians and managers
  • Analytical technicians and QC managers
  • Engineers working in the pharmaceutical industry
  • Specialists in qualification and validation
  • Development personnel involved in technology transfer
  • Quality Assurance personnel

The current regulatory environment imposes far reaching responsibilities on the Pharmaceutical industry. Increasing competition and rising costs push companies to seek greater efficiency without compromising on getting safe and efficacious medicines to patients. The double pressures of more rigorous regulations and greater competition have been strong factors in the development of new management strategies so that companies can remain “in the game”.

The course looks at ICH Q8, Q9, Q10 and Q11 and investigates how these guidelines can be used in already compliant GMP facilities (or those seeking compliance) with a view to improving the efficiency of existing process yet maintaining, or improving, the quality of your processes, products and services.

This course offers a high level of interactive, dynamic problem solving situations. The course directors recognize that many courses can provide information, but information can only be turned into real knowledge through the depth of understanding that comes from sharing experience and exchanging ideas. This is why a workshop approach is so valuable.

Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: David Long; Long & Associates International Consultancy Ltd.

David Long worked for Rhône Poulenc Health Division (now Sanofi) in Quality Assurance (QA) for over twenty years where he gained considerable experience in all three Good Practice disciplines, GLP, GCP and GMP. When he left Rhône-Poulenc he was Senior Director R&D worldwide for Quality and for Process Improvement. Mr. Long has since worked as Director of Quality for CHIMEX, a manufacturing subsidiary of the L'Oreal group and now has his own consultancy company.

Mr. Long has always shown a keen interest in promoting professional QA activities. He was a founder member and President of the French QA Society and a founder member and President of the European QA Federation. He was also the founder and Chief Editor of the Quality Assurance Journal, an international scientific journal specifically addressing subjects of interest to the R&D QA personnel.

Mr. Long has lectured and trained widely and been an active participant in developing training in Good Practices and QA working with a number of international groups including the OECD and the WHO. His latest contribution through the WHO has been in the co-authoring of a set of guidelines for research performed upstream of the regulatory scene, called "Quality Practices in Basic Biomedical Research".
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.