Using Records to Identify Root Causes of Non-Compliance

    /John  /C Fetzerspeaker of Training Doyens
    Speaker: John C Fetzer


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    Duration: 60 Minutes
    Product Code: 50028
    Level: Intermediate

OVERVIEW

Records are temporal and non-compliance occurs at a specific time. These can be compared to get clues of the root cause of the non-compliance.

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 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.

WHY SHOULD YOU ATTEND

Fear, uncertainty and doubt (FUD) liner for the marketing purpose (Between 250 - 500 words): 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 non-compliance.

AREAS COVERED

  • Laboratory records
  • The non-compliance – Symptoms
  • Assessing possibilities
  • Comparing the incident time to the recordkeeping
  • Investigation and cycling back

LEARNING OBJECTIVES

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.

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

SPEAKER

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

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