The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: May 24, 2018 from 1pm to 2:30pm
Street: 9106 Seven Locks Road
Website or Map: https://www.compliancetrainin…
Event Type: online, /, webinar
Organized By: Sam Miller
Latest Activity: Apr 26, 2018
The term Quality System began appearing in FDA publications and guidances about the turn of the century. In 2008 the FDA and ICH released ICH Q10, The Pharmaceutical Quality System and many of the FDA publications are based on the Quality System philosophy. Therefore, it is important that personnel in the pharmaceutical industry understand the Quality Philosophy and the impact this can and should have on policies and procedures that impact every-day activities in a pharmaceutical firm.
The objective of tis webinar is to educate individuals within the pharmaceutical industry of the impact ICH Q10, the Pharmaceutical Quality System will have on the way we manage compliance in the coming years.
Areas Covered in the Session :
Who Will Benefit:
John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.
In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has audited and consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.