Laboratory Instrument Calibration; Current FDA Regulatory Requirements and Best Practices

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Jerry Lanese Ph.D. Biography>>>

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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 live training 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 live training webinar 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 calibrations traceable to national references. The discussion applies the concepts discussed to specific key instruments found in the testing laboratory.

Learning Benefits:
-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.

Webinar outline and time breakdown:

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Live Lecture Part 1,
10:30 AM Break
10:40 AM Live Lecture Part 2,
11:30 AM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A Copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Senior management
  • Production management
  • Quality management
  • Quality Assurance
  • Quality Assurance Product Reviewers
  • Regulatory
Schedule & Deliver this Live Training Webinar Privately to Your Group


Instructor: John G. (Jerry) Lanese Ph.D.

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. Since leaving graduate school, Dr. Lanese has had post doctoral research appointments, taught at the college level, filled several Quality Unit positions in the pharmaceutical industry and for the past 15 years he has been an independent consultant, with a focus on the FDA regulated industries. As part of his consulting practice Jerry lectures throughout the world on a variety of topics related to Quality Systems. 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… Full Bio>>>

 

Course Number: 272

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland