Webinar On "Effective Strategies to Manage Validation In Conformance With The Pharmaceutical Quality System"

ICH Q10, The Pharmaceutical Quality System, which was released to the international pharmaceutical industry in 2008, includes the concept of the product lifecycle. Since that time, the lifecycle approach has been applied to all aspects of pharmaceutical products and processes. ICH Q8, Pharmaceutical Development, and ICH Q9, Quality Risk Management, are closely integrated with ICH Q10. In 2011, the FDA issued its Guidance for Industry, Process Validation: General Principles and Practices. This guidance integrates quality system concepts from ICH Q8, ICH Q9 and ICH Q10 including lifecycle and identifies the three stages of the process validation lifecycle. The Europeans followed with a similar guidance for process validation including the lifecycle concept. 

The following areas will be covered in this audio seminar.

• The FDA Process Validation Guidance
• EU Annex 15
• ICH Q8: Pharmaceutical Development
• ICH Q9; Quality Risk Management
• The Pharmaceutical Quality System ICH Q10; The Quality System

• Management at all levels who are responsible for process development and validation
• Personnel who are responsible for
  1. Product development
  2. Process transfer
  3. Process validation
  4. Demonstration that a process continues to perform in a state of control
• QA, personnel who are responsible for the review and approval of process validation protocols and reports
• Validation specialists.

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 he has managed Analytical Research, Quality Control and Quality Assurance functions.