Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2017

  • 18 Jan 2017
  • Webinar

Description

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2017 is a webinar that covers topics such as:

  • The Barr Decision of 1993 and its impact on OOS investigations
  • What constitutes an atypical or Out of Specification result?
  • Reporting data
  • The FDA guidance for industry on investigating OOS test results
  • Creating an investigation checklist
  • Conducting the investigation
  • Retesting
  • Considering other batches
  • Documenting the investigation
  • Evaluating the outcomes: Is there an assignable cause?
  • Utilizing outcomes for continuous improvement

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2017 is intended for:

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

Past Events

Important

Please, check "Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance
Health & Medicine: Medical laboratories, Pharma
Industry: Chemical

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