Calibration in FDA Regulated Laboratories

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Build or Improve Your Laboratory Instrument Calibration Program in Compliance with FDA Rules!

The Food and Drug Administration (FDA)’s Form 483 and their Warning Letter observations cite calibration in the laboratory as an important issue. A laboratory instrument calibration program is essential for providing assurance that instruments report accurate analytical results. Paragraph 160(b)(4) of Subpart I, Laboratory Controls, of GMPs lay out the expectations for this program. Yet, laboratories often lack the resources or training to effectively manage the laboratory instrument calibration program or laboratory personnel don’t understand the significance of the calibration program, or in some cases, the laboratory program is not effectively integrated with the site calibration program. Laboratory personnel may even be overwhelmed with terms such as measurement uncertainty, traceability, limits of accuracy or precision and calibration interval. 

This session with expert speaker Jerry Lanese will help fill the knowledge gap and provide you, as 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. Jerry will build on the terminology found in 21CFR160(b)(4) and will introduce other terminology and concepts not found in the regulation, which are necessary for an effective calibration program, such as instrument classifications. He will apply 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 concepts discussed here will be applied to specific key instruments found in the testing laboratory.

Session Highlights

  • Identification of the regulatory and technical requirements for calibration.
  • What should be included in a calibration program.
  • What is the importance of a data-based calibration interval and what are the limits of accuracy and precision.
  • How measurement uncertainty impacts the process when limits of accuracy are being established.
  • How test instruments are classified.
  • Current practices in the calibration of specific instruments.

Session Outline:

  • Calibration in the Laboratory
    • Requirements
    • Relationships
    • Responsibilities
  • Elements of a Calibration Program
    • Classification
    • Measurement Uncertainty
    • Specific Calibration Procedures
  • ICH Q10 Pharmaceutical Quality System
  • Need for Accurate Measurements
  • Components of Data Quality
  • The 4Q Model
  • Regulations and Standards
    • 21 CFR 58
    • 21 CFR 211
    • 21 CFR 111
    • 21 CFR 820
    • ICH-Q7A
    • ISO 9001; 10012; 13485; 17025
  • Guidance on Calibration
    • USP 1251
    • USP 41
  • FDA Observation
  • Operational Qualification
  • Calibration Program

Who should attend?

  • 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

Order Below or Call 1-866-458-2965 Today

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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
More Events By The Speaker

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