Webinar On "ICH Q10 – A Focal Point for Contemporary Compliance"

The term Quality System began appearing in FDA publications and guidances about the turn of the century. In 2008 the FDA and ICH released ICH Q10, The Pharmaceutical Quality System and many of the FDA publications are based on the Quality System philosophy. Therefore, it is important that personnel in the pharmaceutical industry understand the Quality Philosophy and the impact this can and should have on policies and procedures that impact every-day activities in a pharmaceutical firm.

1. ICH Q10; The Pharmaceutical Quality System and how it impacts compliance to the CGMPs?
2. The impact of ICH Q8; Pharmaceutical Development, ICH Q9; Quality Risk Management and the 2011 FDA Guidance on Process Validation
3. Regulatory requirements vs. FDA expectations
4. Recent FDA observations that demonstrate transition to the Pharmaceutical Quality System
5. Evolving GMP interpretations
6. A foreign currency
7. denominated interest-bearing asset or liability hedged with a cross-currency interest rate swap
8. Financial statement presentation and disclosure requirements

• Personnel involved in the production and control of pharmaceutical products
• Pharmaceutical development
• Unit managers
• Senior managers in the pharmaceutical industry

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.

In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has audited and consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.