Using Records to Identify Root Causes of Non-Compliance


Instructor: John Fetzer
Product ID: 705345

  • Duration: 60 Min
This webinar will discuss the use of records to identify root causes of non-compliance in GLP or ISO 17025 compliant laboratory.
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Why Should You Attend:

An out-of-compliance under GLP or ISO 17025 is a discreet and specific event. Its occurrence has major consequences for the laboratory operation. Can the incident and its timing give clues to that caused the non-compliance?

Tracking down the cause of a non-compliance can be a time-consuming and difficult task. But in a compliant laboratory there are numerous records covering everything done within the laboratory. These records are a coordinated and interlocking system that can be a key tool in finding certain root causes. This webinar will describe the approach and some examples of how to do this.

Areas Covered in the Webinar:

  • What records are required in a compliant laboratory?
  • Non-compliance
  • Symptoms – What is normal?
  • How is this abnormal?
  • What are possible causes?
  • How are these tracked by the records?
  • Case study

Who Will Benefit:

  • Research Associates
  • Technicians
  • Chemists
  • Quality Officers
  • Laboratory Supervisors
  • QA Managers and Personnel
  • QC Managers and Personnel
  • Quality System Auditors
  • Regulatory Compliance Associates
  • Documentation Specialists
Instructor Profile:
John Fetzer

John Fetzer
Consultant, Fetzpahs Consulting

John C. Fetzer, has had over 30 year experience in HPLC methods development. He has authored or co-authored over 50 peer-reviewed papers on liquid chromatography, has served on the editorial advisory boards of the Journal of Chromatography, Analytical Chemistry, and Analytical and Bio analytical Chemistry.

Topic Background:

Data quality and compliance to a required level of performance are measured by statistical tools. Usually in compliance there is a very heavy weighing towards only 3-sigma deviations. But statistics gives much more than that. There are other signs that being “out of control” is a building situation. These other statistical patterns can be used to trigger preventive actions without the dire consequence of a non-compliance.

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