Using Records to Identify Root Causes of Non-Compliance

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

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

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.

For more detail please click on this below link:

https://goo.gl/XCVQxV

Email: [email protected]

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