Moving from GMPs to the Pharmaceutical Quality System - What Does It Take ?

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Stay Compliant with the ICH Q10, the Pharmaceutical Quality System. Here’s how

Since the turn of the century, the FDA has been promoting the concept of the Pharmaceutical Quality System and issued guidance on the topic. In 2008, the International Conference on Harmonization (ICH) issued ICH Q10, the Pharmaceutical Quality System. There has been little discussion or guidance on what the industry should do to be compliant with the concepts of the pharmaceutical quality system.

Our expert presenter Jerry Lanese, in this audio seminar, will discuss in details what a firm should do to be compliant with the concepts of ICH Q10, the Pharmaceutical Quality System.

Plus, you will learn the difference between what the industry will be expected to between the GMPs of 2000 and the pharmaceutical Quality System and what should be done to assure that their organization is ready for the FDA expectations.

Here are few additional topics covered in the session:

  • What is the Pharmaceutical Quality System?
  • Learn what are the management responsibilities
  • What regulations can the FDA site in inspectional observations?
  • How to transition to the PQS?
  • Relationship of the PQS to other ICH and FDA guidances

Who should attend? Senior management, Quality System Directors and Managers, Quality Assurance Directors and Managers, Quality Control Directors and Managers, Quality personnel at all levels.

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. 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...   More Info
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