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Calibration in the Laboratory
Getting it Right!
Conducted by Jerry Lanese, Ph.D., CMC
Principal - Lanese Group
May 8, 2013
Calibration in the laboratory has been the subject of FDA Form 483 and Warning Letter observations. The purpose of a laboratory instrument calibration program is to provide assurance that instruments provide accurate analytical results. The expectation for this program is spelled out in paragraph 160(b)(4) of Subpart I, Laboratory Controls, of the GMPs. Often laboratories lack the resources or training to effectively manage the program for laboratory instrument calibration, laboratory personnel do not understand the significance of the calibration program or the laboratory program is not effectively integrated with the site calibration program.
Laboratory personnel may be overwhelmed with terms such as measurement uncertainty, traceability, limits of accuracy or precision and calibration interval. This webinar will help fill the knowledge gap and provide laboratory management and analysts with the basic information to facilitate the improvement of an existing program or implementation of a new program for laboratory Instrument calibration.
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 of critical, non-critical and utility. It applies measurement uncertainty or test accuracy ratio to specific calibration procedures and the selection of standards to provide scientifically sound traceability of calibrations to national references. The discussion applies the concepts discussed to specific key instruments found in the typical testing laboratory.
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All registrations include handout materials. Once you’re registered, you will receive via e-mail (the e-mail address you provide in your registration) the presentation handout materials the day before the seminar.
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|Get the MP3 file and handout
GMP130508E - MP3 audio file and handout materials
Calibration in the Laboratory
Jerry Lanese, Ph.D., CMC
An independent consultant with experience in the area of quality systems, quality management and FDA regulatory compliance. More than three decades of experience in quality systems, quality system development, quality system audits, method development, quality control laboratory management, quality assurance, regulatory compliance and training.
Dr. Lanese possesses a thorough knowledge of the Baldrige Criteria, FDA Quality System approach, analytical instrumentation, product testing, specification development, validation, documentation review, GMPs, NDAs and quality management concepts. He is a member of ASQ, IMC, ACS, Sigma Xi, and the Kansas Center for Performance Excellence.
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