Technical Advisor for Aseptic Processing Conference Karen Ginsbury, B. Pharm, M.Sc. M.R.Pharm.S. PCI Pharmaceuticals Consulting, Israel, Ltd.   Karen Ginsbury President, PCI, Pharmaceutical Consulting Israel, obtained a Bachelors degree in pharmacy from the University of London, followed by a Masters degree in Microbiology, also at the London University.   A member of the Royal Pharmaceutical Society of Great Britain, Karen Ginsbury spent one year working for Smith and Nephew Pharmaceuticals UK in product development, before moving to Teva Pharmaceuticals currently the world’s largest generic manufacturer.  Karen worked in the Quality Assurance department, initially responsible for QA of sterile production.  Later she was made responsible for establishing and managing the Compliance Department, which included setting up a documentation centre serving three different sites, a company-wide training program and performing compliance audits in-house and for suppliers.  Additional duties included overseeing validation programs and accompanying regulatory audits (FDA, MCA etc).   Upon leaving Teva Pharmaceuticals in 1994, Karen Ginsbury founded her own consulting company which provides consulting services to over 30 companies including API manufacturers, pharmaceutical and biotech companies.  Karen Ginsbury regularly participates in international pharmaceutical forums presenting on topics such as water systems, pharmaceutical research and development, environmental monitoring and others.  Karen has written a book on compliance auditing published by Interpharm Press USA and purchased amongst others by FDA. An active member of PDA, an International Association for Advancement of Pharmaceutical Sciences, well known for its interaction with FDA, Karen Ginsbury is founder member and immediate past President of the Israel Chapter of PDA.