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Using Records to Identify Root Causes of Non-Compliance

Event Details

Using Records to Identify Root Causes of Non-Compliance

Time: November 8, 2017 from 1pm to 2pm
Location: 26468 E Walker Dr, Aurora, Colorado 80016-6104
Street: 26468 E Walker Dr, Aurora, Colorado 80016-6104
City/Town: Aurora
Website or Map: https://goo.gl/XCVQxV
Phone: 7209961616
Event Type: online, webinar
Organized By: Training Doyens
Latest Activity: Oct 9, 2017

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Event Description

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: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

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