Webinar On "Quality Metrics in the Laboratory"

In this webinar we will discuss the impact of an FDA focus on Quality Metrics on laboratory operations.

1. Quality Metrics – what are they
2. The regulatory requirements for metrics
3. FDA interest in Metrics
4. Expectations for quality metrics in the laboratory
5. Quality metrics that should be implemented in the laboratory

• Quality Control Laboratory management
• Quality Control laboratory supervisors
• Quality Control laboratory analysts
• Quality Assurance auditors
• Quality Assurance managers
• Analytical Development laboratory Personnel

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.