The pharmaceutical industry has had GMPs since the 1960s. In the 1970’s and well into the 1980’s validation practices were added on. In the 1990’s with the Barr court case, OOS results took a front row seat. Y2K long forgotton was for year 2000 when we thought all our computers would go nuts…surprisingly few did. In 2008 the Heparin disaster brought supply chain under the lens and it has remained there. Risk Management and supposedly Knowledge Management were added, along
with Management Review and Process and Performance Monitoring, CAPA and Change Management around 2008 when ICH Q10 the “Pharmaceutical Quality System” was finalized.
Between 2010 and 2020/ 21 Data Integrity, Health Based Exposure Limits and of late “effectiveness” as in CAPA effectiveness, training effectiveness, change effectiveness have been the “hot” issues.
This webinar will investigate what elements allow a Quality Management System to work and what harms that system. Is CAPA a burned out concept and if not, how come it was removed from ISO 9001:2015 which is a model for a modern, effective QMS.The objective of this webinar is to understand what Quality is and what a QMS is supposed to do and how it should do it. Where the GMPs fit into the QMS and how, with intense and close regulatory scrutiny, is it possible to manage a truly effectiveness and robust system.
The lecturer
Karen Ginsbury is a UK trained pharmacist with an MSC in microbiology from Birkbeck College, University of London. With over 30 years of industry experience, both working in the Quality Unit and as an independent consultant, Karen brings you her observations from hundreds of audits, tens of clients around the world and helping to set up, improve and maintain GMP compliant systems, or restore Quality Management Systems after they have failed. Prior to Covid, Karen regularly lectured around the world, and currently continues to lecture regularly via the internet.
14 июл 2021
