ICH Q10 – Its Impact on Compliance

Event Information
Product Format
Prerecorded Event
Conference Date
Tue, Oct 06, 2015
90 minutes
Product Description

Understand How the Quality System Concepts Delineated In ICH Q10 Impact the Interpretation of the US GMPs

Since the turn of the century, the FDA has been telling the industry that it will regulate using a quality system model; encourage risk-based compliance management; and implement science-based regulation of product quality. Prior to 2008, the agency published several guidance and draft guidance that promote a quality system approach. In 2008, the International Conference on Harmonization released ICH Q10, The Pharmaceutical Quality System, which has become the center point for subsequent guidance and regulations published by ICH, FDA, the European Union and other pharmaceutical industry focused organizations.

The FDA is expecting pharmaceutical firms to have a lifecycle approach to all aspects of commercial production and product and test method development. The concepts identified in ICH Q10 are the foundation for most FDA inspectional activities and consistent with quality system concepts applied through a wide range of industries beyond the FDA regulated industries. 

This webinar by expert speaker Dr. Jerry Lanese will discuss how the quality system concepts delineated in ICH Q10 impact the interpretation of the US GMPs and the content of guidance and regulations published in the US and EU. The session will help personnel in Management, Quality Assurance, Pharmaceutical and Test Method Development understand the new guidance and anticipate future emphasis by the regulators.

Session Highlights

  • Overview of ICH Q10
  • Understanding the activities that lead to the development and publication of ICH Q10
  • Product Lifecycle – the consistent theme through ICH Q10
  • Other guidance and new regulations
  • The elements and enablers of the Pharmaceutical Quality System
  • Possible new areas of emphasis by the FDA

Session Agenda:

  • ICH Q10, The Pharmaceutical Quality System
  • ICH Q9, Quality Risk Management
  • ICH Q8, Pharmaceutical Development
  • 21CFR 211
  • EU GMPs
  • FDA Process Validation Guidance
  • USP Stimulus Article on Test Method Validation

Who Should Attend

  • Senior management
  • Operations Directors, Managers and Supervisors to include:
    • Production
    • Packaging
    • Materials
    • Quality Assurance
    • Quality Control
    • Technical support
  • Those involved with Process and Test Method Validation and Development
  • Quality Assurance and Control personnel

At the Q&A session following the live event, ask a question and get advice unique to your information management situation, directly from our expert speaker.

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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
More Events By The Speaker

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