In this webinar we will discuss the impact of an FDA focus on Quality Metrics on laboratory operations.
Objective :
The objective of this webinar is to alert and educate Quality Control laboratory management and line personnel on how an FDA interest in quality metrics may impact the laboratory and how the laboratory can implement metrics to provide a higher level of control of laboratory operations.
Areas Covered in the Session :
Quality Metrics – what are they
The regulatory requirements for metrics
FDA interest in Metrics
Expectations for quality metrics in the laboratory
Quality metrics that should be implemented in the laboratory
Who Will Benefit:
Quality Control Laboratory management
Quality Control laboratory supervisors
Quality Control laboratory analysts
Quality Assurance auditors
Quality Assurance managers
Analytical Development laboratory Personnel
About Speaker:
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.
Dr. Lanese focuses on training. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.
