One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.
Given this fact, it is important for professionals who work in laboratories to ensure that the laboratory has an instrument calibration program that assures that the instruments are calibrated at appropriate intervals using specific procedures that define the standards and tolerances that are relevant to and appropriate for the intended use of the instrument.
A well-structured learning session on calibration in the laboratory
All the core and supplementary aspects of laboratory calibration will be taught at a highly valuable learning session that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.
At this webinar, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To gain complete understanding of all the important aspects of laboratory instrument qualification, please enroll for this webinar by visiting What Should be Included in a Calibration Program
Imparting understanding of the standards
The speaker at this webinar will show to participants how to apply measurement uncertainty or test accuracy ratio to specific calibration procedures, as well as the selection of standards needed to provide scientifically sound calibrations traceable to national references.
Building on the terminology found in 21CFR160 (b) (4); Jerry will base his teaching by relating and applying the concepts discussed to specific key instruments found in the testing laboratory. This learning will improve participants’ understanding of calibration and help them understand the ways by which to apply these concepts.
Jerry will cover the following areas at this session:
o The regulatory and technical requirements for calibration.
o What should be included in a calibration program
o The importance of a data-based calibration interval and limits of accuracy and precision
o The impact of measurement uncertainty when establishing limits of accuracy
o The classification of test instruments
o Current practices in the calibration of specific instruments
Laboratory Managers, Laboratory Supervisors, Laboratory Analysts that are responsible for the calibration of laboratory instruments, Laboratory Record Reviewers, Quality Assurance record reviewers and Quality Assurance Managers will gain important learning from this webinar.
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