A Comprehensive Review of ICH Q10 Pharmaceutical Quality System and the FDA’s Latest Expectations Regarding the Integration of ICH Q10 Concepts in to GMP Systems
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Jerry Lanese Ph.D. Biography>>>
Available Live On-Demand
In recent years the FDA has encouraged the pharmaceutical industry to adopt Quality System concepts into the production and control of pharmaceutical products. In 2008, the Agency released a guidance, ICH Q10, The Pharmaceutical Quality System. Two additional, supporting guidances; ICH Q8, Pharmaceutical Development and ICH Q9, Quality Risk Management have also been released. It is clearly the expectation of the FDA that the industry implement the concepts found within ICH Q10, ICH Q9 and ICH Q8 into programs and systems that support compliance with the GMPs.
In this live training webinar we will discuss ICH Q10, The Pharmaceutical Quality System and how the concepts and systems found in this guidance, as well as ICH Q9 and ICH Q8, are integrated into the GMPs.
This Live Webinar Will Cover:
- FDA actions that encourage or require the implementation of ICH Q10.
- ICH Q10.
- Integration ofICH Q10 concepts into GMP systems.
- Guidances that support ICH Q10.
- Regulatory actions that support implementation of ICH Q10.
- Understand the following:
* The regulatory path leading up to ICH Q10
* Product lifecycle
* Management responsibility
* Quality System elements
* Quality system enablers
* FDA Expectations & Recomendations
- Implementation of the Quality System elements into compliance programs.
- Ways in which the FDA has included the concepts of the Quality System into enforcement of the GMPs.
- Recent FDA actions designed to reduce the burden of site inspections while sustaining regulatory oversight.
Webinar outline and time breakdown:Time*
|09:15 AM||Log In Period|
|09:40 AM||Introduction to topic,|
|Actions leading to the publication of ICH Q10,|
|ICH Q10 elements,|
|ICH Q10 enablers,|
|Integrating ICH Q10 concepts into the GMPs,|
|10:40 AM||Integrating ICH concepts into the GMPs (continued),|
|FDA actions that support ICH Q10,|
|11:30 AM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Senior management
- Production management
- Quality management
- Quality Assurance
- Quality Assurance Product Reviewers
Instructor: John G. (Jerry) Lanese Ph.D.
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. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology. In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry… Full Bio>>>
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