Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: John (Jerry) Lanese

The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

This live webinar training will provide a clear process for compliant laboratory OOS investigations.

Why should you Attend: The FDA is inspecting laboratory operations very closely, with an emphasis on how the laboratory investigates Out-of-specification and out-of-tolerance observation investigations. All Laboratory and Quality Assurance management, analysts and reviewers should be aware of the FDA expectations for procedures that define a complete, scientifically sound investigation of each out-of-specification and out-of-trend laboratory observation and evidence that laboratory personnel are following the procedures. This training will build the foundation for the implementation of adequate procedures and provide a review of existing procedures and practices.

Areas Covered in the Session:
– Why the regulators are concerned about the handling of OOS investigations.
– The FDA model for handling OOS investigations.
– Commonly accepted terminology such as repeat testing and retesting.
– How the laboratory can meet regulatory expectations for OOS investigations.
– The interaction between the laboratory and other units in the organization.

Who Will Benefit:
– Laboratory Managers
– Laboratory Supervisors
– Laboratory Analysts
– Quality Assurance Managers
– Quality Assurance record reviewers

John (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 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 lectures throughout the world on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and national seminar and conference providers. He was named the Best Seminar Presenter of the year 2001 by the Institute of Validation Technology.

In 2005, his article “Training and the Laboratories” was selected as best article of year by the Journal of GXP Compliance. Recently, in 2007, Jerry received the Kenneth Chapman Industry Recognition Award for his contributions to the Pharmaceutical industry. Jerry is a member of the Editorial Board of the Journal of GXP Compliance. He has been active in the Kansas Award for Excellence program, a Baldrige Criteria based program, for the past fifteen years. He has served as Examiner, Lead Examiner and Judge and is currently the Director of the Kansas Award for Excellence Program. In addition, he served as a Baldrige Examiner in 2008. Dr. Lanese is also a member of American Society for Quality, AOAC and the Institute for Management Consultants and is a Certified Management Consultant (CMC). He is listed in Madison Who’s Who. He was active in the Kansas Award for Excellence program, a Baldrige Criteria based program, for seventeen years. He served as Examiner, Lead Examiner, Judge and the Director of the Kansas Award for Excellence Program. In addition, he served as a Baldrige Examiner in 2008. On the personal side, Jerry is active in two Toastmasters clubs in the Johnson County, KS area, and is the president of Kansas City Ragtime Revelry, an organization that promotes ragtime and early American music.