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.

Objective:

   The objective of this webinar is to inform and educate individuals who work in, manage, audit and review documents generated by Quality Control Laboratories and .Analytical Development Laboratories about systems that should be in place to support contemporary Quality Systems.

Areas Covered in the Session :

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

Who Will Benefit:

   Managers
   Supervisors
   Analysts working the Quality Control
   Analytical Development Laboratories
   Quality Assurance Laboratory Document Reviewers
   Quality Assurance Auditors

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.