Webinar On "Laboratory Controls – In the Quality System Environment"

Although the pharmaceutical industry is operating under a regulation written in the mid 1970s, there has been a considerable change in technology and the FDA has released a number of guidance documents that impact what is considered to be compliance. In this webinar we will discuss laboratory controls expected by the regulators and consistent with recent guidance and industry practice.

• Trending
• OOS investigations
• Test procedures
• Analytical method validation
• Test method uncertainty
• Instrument qualification and calibration
• Quality Metrics in the Laboratory

1. Managers
2. Supervisors
3. Analysts working the Quality Control
4. Analytical Development Laboratories
5. Quality Assurance Laboratory Document Reviewers
6. Quality Assurance Auditors

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.