FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control Webinar - ResearchAndMarkets.com

The "FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control" webinar has been added to ResearchAndMarkets.com's offering.

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Provider: 
Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
Wednesday, June 22, 2022
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Tags: 
Health, Pharmaceutical, QC, Certificate of pharmaceutical product, OOT, FDA, Knowledge, CAPA, Failure, Documentation, SOP (TV program), OOS, Vaccine, Pharmaceutical industry, Risk management, Medical device, Maintenance (technical), Industry
Summary
Key Points: 
  • The "FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control" webinar has been added to ResearchAndMarkets.com's offering.
  • This session will equip you with the knowledge and comprehensive understanding of FDA requirements for Out-of-Trend Results in pharmaceutical quality control.
  • FDA's guidance on OOS test results requires failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results.
  • Managing OOT results also helps to avoid time consuming OOS results.


The "FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control" webinar has been added to ResearchAndMarkets.com's offering.

This session will equip you with the knowledge and comprehensive understanding of FDA requirements for Out-of-Trend Results in pharmaceutical quality control.

FDA's guidance on OOS test results requires failure investigations and other steps for Out-of-Specification (OOS) and Out-of-trend (OOT) results. While most companies are familiar with and have procedures for OOS results, this is not the case for OOT situations.

The guide states: `Although the subject of this document is OOS results, much of the guidance may be useful for examining results that are out of trend`. Managing OOT results also helps to avoid time consuming OOS results. The industry is unsure how to interpret and implement the FDA guidance.

Key Topics Covered:

  • FDA regulations and guidelines.
  • FDA's final Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
  • Difference between OOS and OOT results.
  • Developing SOPs for OOT situations and laboratory failures.
  • Investigating OOT results: what and how.
  • Retesting of OOT results.
  • Using historical data for OOT evaluation.
  • Using QC samples and product control charts for evaluation.
  • Developing corrective and preventive action plans.
  • Finding the root cause for OOT results.
  • Strategies to avoid OOS situations BEFORE they occur.
  • FDA compliant documentation of OOS, OOT, failure investigations, root causes and CAPA.

Who Should Attend:

  • Analysts
  • Lab Supervisors and Managers
  • QA managers and personnel
  • Pharmaceutical R&D personnel
  • Documentation
  • Consultants
  • Contract laboratories
  • CROs

For more information about this webinar visit https://www.researchandmarkets.com/r/jio2fj

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