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>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

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.

Learning Benefits:
- 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:

09:15 AM Log In Period
09:30 AM Introduction
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,
10:30 AM Break
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
  • Regulatory

strong> Schedule & Deliver this Live Training Webinar Privately to Your Group

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>>>


Course Number: 275

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland