Laboratory Instrument Calibration; Current FDA Regulatory Requirements and Best Practices
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Jerry Lanese Ph.D. Biography>>>
Available Live On-Demand
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.
-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|
|9:40 AM||Live Lecture Part 1,|
|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
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>>>
All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.
Live Training Benefits:
Live Training Benefits:
• Pharma Webinars training webinars and programs are presented exclusively as live events only.
• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.
• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.
• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.
• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.
• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.
• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.
• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.
• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.