Moving from GMPs to the Pharmaceutical Quality System

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, May 17, 2017
60 minutes
Product Description

What Pharmaceutical Firms Must Implement to Be Compliant

The FDA has issued a guidance document that supports a pharmaceutical quality systems approach (PQS) to pharmaceutical current good manufacturing practices (CGMP).

In order to implement a PQS, most pharmaceutical firms will have to make very significant cultural changes to their current operations.

This webinar by expert speaker Dr. Jerry Lanese will focus on the critical changes firms need to put in place and discuss the systems that a firm must implement to be compliant with CGMP and the Pharmaceutical Quality System.

Session Highlights

  • 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

Who should attend

  • Senior Corporate Management
  • VP-Quality
  • Director-Quality
  • Manger-Quality
  • Directors and Managers of all Disciplines

At the Q&A session following the live event, ask a question and get advice unique to your 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
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