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2019 - Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results



VenueOnline Event, USA - United States 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
Considering Other Batches
Corrective and Preventive Action (CAPA)
Documenting the Investigation
Case Study
Questions and discussion

Last modified: 2019-04-04 20:36:21