Calibration in the Laboratory

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

Identify the Regulatory Requirement for Calibration in the Laboratory

The Pharmaceutical Product GMPs have some very specific requirements for calibration of laboratory instruments (21CFR211.160(b)(4)) and the FDA has written observations of non-compliance with these expectations.  In some cases, the observation is incorrectly positioned as non-compliance with the requirement for calibration when the actual problem is with another system.  In other cases the components of the calibration program are in place and the organization is not following its own procedures.  The organization should have the required programs in place and understand how the laboratory calibration program relates to other calibration programs that might exist at the site and other components of the quality system. With this knowledge the organization can proactively evaluate its calibration program and prevent regulatory observations.

Join Dr. Jerry Lanese in this 90 minute session to get:

  • An understanding of the requirements for the calibration of laboratory instruments
  • An appreciation for the application of the concept of intended use to the calibration program
  • An appreciation of the application of  the concept of measurement uncertainty to instrument calibration
  • A system for the classification of instruments that can limit the requirements of the calibration program
  • Information on the calibration of several specific laboratory instruments

Topics covered in the session:

  • The regulatory requirement for calibration in the laboratory, 21CFR211.160(b)(4), and how it applies to the daily operation of the Quality Control and Development Laboratory
  • The relationship between the laboratory calibration program and the site calibration program
  • The system for the classification of test equipment.
  • Remedial action in the event of an as found out-of-tolerance.
  • Measurement uncertainty (Test Accuracy Ratio).
  • Calibration of:
    • Balances
    • HPLCs
    • Pipets
    • Particle counters

Some laboratories often do not understand what is required to have compliant program for the calibration of the laboratory instruments.  Other laboratories have calibration programs that result in extra, resource consuming activities.  With a thorough knowledge of the requirements and the terminology, a laboratory can develop and implement an effective, science-based laboratory instrument calibration program.

Who should attend? Laboratory Managers, Laboratory supervisors, Laboratory analysts, especially any who are responsible for the coordination of the Laboratory calibration program, Quality Assurance managers, Internal auditors

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1-866-458-2965

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1-919-287-2643

About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. 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...   More Info
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