2017 - Webinar On "Moving from GMPs to the Pharmaceutical Quality System"

Description :
Since the turn of the century, the FDA has been promoting the idea of a Pharmaceutical Quality System. This is supported by an FDA Guidance Document: Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations and ICH Q10; the Pharmaceutical Quality System. It is clear from FDA Form 483, Report of Observations given to pharmaceutical manufacturers and Warning Letters that the FDA is interpreting the GMPs (21CFR211) consistent with concepts found in ICH Q10; The Pharmaceutical Quality System. In this audio seminar we will discuss the systems that a firm must implement to be compliant with the CGMPs which is actually an implementation of the Pharmaceutical Quality System.
Objective :
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 :
ICH Q10; The Pharmaceutical Quality System and how it impacts compliance to the CGMPs?
The impact of ICH Q8; Pharmaceutical Development, ICH Q9; Quality Risk Management and the 2011 FDA Guidance on Process Validation
Recent FDA observations that demonstrate transition to the Pharmaceutical Quality System
How to prevent observations
Evolving GMP interpretations
About Speaker:
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.