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Tuesday, September 19


INVESTIGATING OUT-OF-SPECIFICATION (OOS) TEST RESULTS IN THE LABORATORY

Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA
Guidance and Latest Expectations

By The Grcevents
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DATE AND TIME

Tuesday, September 19 · 7 - 9pm CEST


LOCATION

Online


REFUND POLICY

Contact the organizer to request a refund.
Eventbrite's fee is nonrefundable.


ABOUT THIS EVENT

 * 2 hours
 * Mobile eTicket


DESCRIPTION

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 Guidances 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 will Benefit

The following individuals or disciplines will benefit from attending this
Webinar:

 * Senior management
 * Production management
 * Quality management
 * Quality Assurance
 * Quality Assurance Product Reviewers
 * Regulatory


TAGS

 * Online Events
 * Things To Do Online
 * Online Classes
 * Online Other Classes
 * #test
 * #results
 * #investigating
 * #oos
 * #outofspecification


ABOUT THE ORGANIZER

Organized by
The Grcevents
 * Contact
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$229 – $787
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