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
Why should you Attend:
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.
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
Who Will Benefit:
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.