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

Event Details

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

Time: August 17, 2017 from 1pm to 2:30pm
Location: Online
Street: 9106 Seven Locks Road
City/Town: Bethesda
Website or Map: https://www.compliancetrainin…
Phone: 1-844-216-5230
Event Type: webinar
Organized By: Sam Miller
Latest Activity: Aug 10, 2017

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Event Description

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.

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.

Contact Details:    
Organiser      : Compliance Training Panel
Email             :
Phone            : 1-844-216-5230  
Speaker         : Jerry Lanese    
Price              : Live - Single : $ 239    
Website         :

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