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

This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation , but necessary for an effective calibration program, such as instrument classifications. It applies measurement uncertainty or test accuracy ratio to specific calibration procedures and the selection of standards to provide scientifically sound calibrations traceable to national references. The discussion applies the concepts discussed to specific key instruments found in the testing laboratory.

Why should you Attend: It is important that the laboratory have an instrument calibration program that assures that the instruments are calibrated at appropriate intervals using specific procedures that define the standards and tolerances appropriate for the intended use of the instrument. In this webinar we will discuss instrument classification, getting the instrument into the calibration program, removing the instrument from the calibration program, instrument classification, limits of accuracy and precision and remedial actions in the event that an instrument is found to be out of tolerance. All of these are elements of a compliant program

Areas Covered in the Session:
– The Regulatory and Technical requirements for calibration
– What Should be Included in a Calibration Program
– The Importance of a data-based Calibration Interval and Limits of Accuracy and Precision
– The Impact of Measurement Uncertainty when Establishing Limits of Accuracy
– The Classification of Test Instruments
– Current Practices in the Calibration of Specific Instruments

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.