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2019 - Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
Date2019-04-25
Deadline2019-04-25
VenueOnline Event, USA - United States 
KeywordsLaboratory Atypical Results; Laboratory OOS Results; Out of Specification
Topics/Call fo Papers
What Constitutes An Atypical or Out of Specification Result?
The FDA Guidance for Industry on Investigating OOS Test Results
Phase I: Initial Laboratory Investigation
Phase II: Full Scale Investigation
Tools for finding the Root Cause
Testing the hypotheses regarding potential root causes
Retesting
Considering Other Batches
Corrective and Preventive Action (CAPA)
Documenting the Investigation
Case Study
Questions and discussion
The FDA Guidance for Industry on Investigating OOS Test Results
Phase I: Initial Laboratory Investigation
Phase II: Full Scale Investigation
Tools for finding the Root Cause
Testing the hypotheses regarding potential root causes
Retesting
Considering Other Batches
Corrective and Preventive Action (CAPA)
Documenting the Investigation
Case Study
Questions and discussion
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Last modified: 2019-04-04 20:36:21