Role of Logbooks and Record Keeping in Identifying Root Causes in Labs

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Objectives of the Presentation

  • What records are there 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?

Why Should you Attend

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.

Who will Benefit

  • Research Associates
  • Lab Chemists
  • Lab Supervisors
  • Quality Officers
  • Supervisors and Managers
  • Quality Assurance Personnel responsible for generating or evaluating test results in a regulated
  • environment
  • GMP auditors
  • Analysts and other laboratory staff
  • Regulatory Affairs
  • Product Development analytical testing Managers and Directors
  • Product Development Analysts
  • Quality Assurance Directors, Managers, and record reviewers

Topic Background

A well-maintained and properly documented laboratory notebook establishes a permanent record of research protocols and results which can be referred to in the future, most commonly in the preparation of scientific papers and reports. Additionally, it can be an invaluable source of information for a variety of purposes, including determination of claims of discovery where new inventions are concerned; demonstration of adherence to standards of good practice, and of academic and ethical integrity; and compliance with contractual provisions permitting sponsors to audit work carried out in pursuit of sponsored research.

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