Investigating Out-Of-Specification (OOS) Test Results In The Laboratory:  FDA Guidance And Latest Expectations Course (ONLINE EVENT: December 10, 2024/ON-DEMAND)
Investigating Out-Of-Specification (OOS) Test Results In The Laboratory:  FDA Guidance And Latest Expectations Course (ONLINE EVENT: December 10, 2024/ON-DEMAND) . (MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations" ...
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(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations" webinar has been added to ResearchAndMarkets.com's offering.

Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely.

The objective of this live training webinar is to develop an understanding of how a compliant laboratory handles the investigation of OOS test observations and how the laboratory interfaces with other units through the laboratory investigation process. The interactive live discussion will be based on the FDA guidance on handling OOS laboratory results and to provide a clear process for compliant laboratory OOS investigations.

Webinar Takeaway



The requirements for laboratory OOS investigations.

Latest Regulatory expectations.

The laboratory OOS investigation process.

Laboratory investigation, Phase I.

Laboratory investigation, Phase II.



Retesting.



Resampling. Communicating with Quality Assurance.

Learning Benefits:



Understand 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 investigation.

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



US - 21CFR211.160, 192

ICH Q7; 11.1 FDA Guidance for the Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Who Should Attend:



Senior management

Production management

Quality management

Quality Assurance

Quality Assurance Product Reviewers Regulatory

For more information about this webinar visit

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https://menafn.com/1108865134/Investigating-Out-Of-Specification-OOS-Test-Results-In-The-Laboratory-FDA-Guidance-And-Latest-Expectations-Course-ONLINE-EVENT-December-10-2024ON-DEMAND
2024-11-08
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(MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations" ...
Investigating Out-Of-Specification (OOS) Test Results In The Laboratory:  FDA Guidance And Latest Expectations Course (ONLINE EVENT: December 10, 2024/ON-DEMAND)