The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: August 16, 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: Jul 23, 2018
The existing GMPs were finalized in 1979 and the industry has changed considerably since that time. In 2001 the FDA announced to the pharmaceutical industry that it would regulate the industry based on good science and risk. Since that time the Agency has partnered with ICH in the release of ICH Q8, Pharmaceutical Development, ICH Q9, Risk Management and ICH Q10, The Pharmaceutical Quality System. FDA has also issued guidances on Process Validation, Quality Metrics and Data Integrity. All of these provide contemporary interpretation for a quality system approach to the enforcement of the existing regulation, the drug GMPs, 21CFR211.
The objective of this webinar is to inform personnel involved with GMP operations in a pharmaceutical firm how the FDA is transitioning the interpretation from the regulation as written in 1978 to a more modern, quality system based interpretation.
Areas Covered in the Session :
In this webinar we will discuss guidances issued by the FDA since the turn of the century and how these bring a contemporary interpretation to the drug GMPs.
Guidance documents discussed will include:
Who Will Benefit:
The following individuals should attend this audio seminar:
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.