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

DUBLIN–(BUSINESS WIRE)–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

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

[email protected]
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