Training & Events

The objective of this interactive live webinar is to develop an understanding of the laboratory investigation of OOS test observations and explain how the laboratory interfaces with the Quality Unit through the laboratory investigation process. The discussion will be based on the FDA guidance in handling OOS laboratory results.

This live training webinar integrates the laboratory OOS investigation activities with information on the general requirements for investigations and the investigations beyond the laboratory discussed within Part I. It suggests procedural approaches to laboratory investigations in compliancy with the latest regulatory expectations.

The objective this interactive Tungsten Shield live webinar training is to provide a clear process for compliant laboratory OOS investigations.

This Live Presentation Will Cover:

-The requirements for laboratory OOS investigations

-FDA Regulatory expectations

-The laboratory OOS investigation process

-Laboratory investigation, Phase I

-Laboratory investigation, Phase II

-Repeat testing

-Retesting

-Resampling

-Communicating with Quality Assurance

Learning Benefits:

-Understand of the developing expectation for appropriate OOS investigations

-Understand of the expectation for the identification of the cause of the OOS results

-Gain a clear insight of the laboratory OOS investigation process

-Learn the terminology associated with laboratory OOS investigations

-Learn about outlier testing

-Understand how the OOS laboratory investigation process relates to the general expectation for deviation investigations

Regulations and Guidances that will be covered (FDA, EU, Canada, WHO, ICH, other)

?US - 21CFR211.160, 192
?ICH Q7; 11.1
?Canada C02.015
?FDA Guidance for the Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production