How to Use Stability Data to Address Temperature Excursions
In this presentation from the Cold Chain & Temperature Control Distribution Online Summit in June -July 2012. Claude Ammann, Managing Director of Claude Ammann Consulting, a company to assist pharmaceutical and biotech firms that wish to enhance their quality capabilities, discusses:
- Increasing flexibility through more effective use of stability data
- Exploring methodologies for testing defining appropriate transport conditions based on current guidance
Have Your Say
Rate this feature and give us your feedback in the comments section below
Claude Ammann Consulting
Claude is Managing Director of Claude Ammann Consulting, a company to assist pharmaceutical and biotech firms that wish to enhance their quality capabilities. He holds a Ph. D. in Sciences from the EPFL, Lausanne, Switzerland and has over 25 years of experience in the Pharmaceutical and related industries. Claude built his industrial experience at Zyma and Ciba-Geigy, both now part of the Novartis group. He started as Manager of Zyma’s HPLC laboratory. Then he served as QC Director and QA Director for the company’s global self-medication sector. His career was given new depth by switching to production as Director Production of Novartis's Nyon site. He later became responsible for site management and QA organization at Valibio, a company focused on recombinant DNA production of clinical trials drugs for third party companies. There he managed projects from the drawing board up to preparation for Swissmedic certification. In May 2003 Claude joined Apoxis, an R&D firm in the oncology segment, as QA/QC Director. In June 2007 Apoxis was taken over by TopoTarget A/S Denmark, an international biotech company dedicated to developing improved cancer therapies. Claude was Site Manager and Director of Quality Assurance / Quality Control for TopoTarget Switzerland SA, based in Lausanne (Switzerland). He has been Responsible Person as qualified by Swissmedic. In 2009 he started his own business to assist pharmaceutical and biotech firms that wish to enhance their quality capabilities.
For more information, contact Claude at http://www.claudeammann.com/en/12/cold-chain-and-temperature-controlled-chain
* = required.