Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

Description

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 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 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

Future Events

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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