Laboratory Instrument Calibration: Current FDA Regulatory Requirements and Best Practices

Duration: 90 Minutes
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.
Laboratory Instrument Calibration
Instructor: John G. Lanese
Product ID: 501728
Objectives of the Presentation
Upon completing this webinar, the participant will understand:
  • 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
Why Should you Attend
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 report 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.

Who will Benefit
Laboratory Managers, Laboratory supervisors, Laboratory analysts, especially any analyst that is responsible for the calibration of laboratory instruments, Laboratory record reviewers, Quality Assurance record reviewers, Quality Assurance managers. Quality Control and Quality Assurance managers, Laboratory Analyst, Internal auditors
$375
Recorded Session for one participant
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  $500.00 Training CD
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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, since then he has been a consultant in the area of quality system and cGMP compliance and has been consulted by 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 and presents webinars on a variety of topics related to Quality Systems, GMPs, APIs, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar 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 the best article of the year by the Journal of GXP Compliance. 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.


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