Book Online Tickets for Conducting Effective Investigations of O, Philadelph. This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, and how to perform investigations to assure both compl

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results

 

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About The Event

This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, and how to perform investigations to assure both compliance and good business decisions. The course stresses timely, consistent investigations focused on identifying the root cause and taking appropriate actions regarding the disposition of the data and the material, as well as corrective or preventive actions to avoid similar situations in the future. There will be an exercise using a participant's example to work through an investigation, as well as ample opportunity for questions and discussion.

 

Learning Objectives:

  • Be familiar with various terms used by regulators associated with investigations of atypical or out of specification results, and how to document those investigations.
  • Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and how to apply it in laboratory situations.
  • Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results.
  • Know the importance of Corrective and Preventative Action (CAPA) and be able to identify appropriate CAPAs.
  • Understand practical strategies to utilize outcomes from investigations for continuous improvement and reduction of future OOS results.

Areas Covered:

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

Who will benefit:

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

For More Info:

https://www.complianceonline.com/out-of-specification-oos-atypical-laboratory-seminar-training-80589SEM-prdsm?channel=meraevent

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