Objectives of the Presentation
Upon completing this webinar, the participant will understand:
Why Should you Attend
- 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
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