Using Records to Identify Root Causes of Non-Compliance
Instructor:
John Fetzer
Product ID: 705345
- Duration: 60 Min
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
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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