Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2018

  • 06 Dec 2018
  • Philadelphia, PA, United States

Description

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2018 covers topics such as:

  • Gauging the impact of OOS results
  • Review of recent FDA Warning Letters regarding OOS results
  • Initiating an Investigation
  • Get familiar with The FDA Guidance for Industry on Investigating OOS Test Results and the terminology inspectors will use
  • Conducting the Investigation
  • EXERCISE: Assess several examples to evaluate how much work is necessary
  • Evaluating the Outcomes: Were you effective in identifying the real problem (root cause)?
  • Documenting the Investigation
  • CAPA
  • EXERCISE: Discuss your challenging investigations and get feedback from the instructor and attendees

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2018 brings together:

  • Chemists
  • Supervisors and Managers in Pharmaceutical (Human or Veterinary)
  • Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment
  • Generic, OTC or Contract Laboratories

Past Events

Important

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Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical laboratories
Science: Chemistry, Laboratories

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