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2020 - Properly Investigating and Remediating OOS Results
Date2020-11-17
Deadline2020-11-07
VenueOnline event, USA - United States 
KeywordsOOS test results training; Implementing CAPA; OOS or atypical result
Topics/Call fo Papers
FDA requirements for handling OOS/ OOT results
Phase I- Laboratory Phase of Investigations
Phase II a Full Scale Investigation
Concluding an Investigation
Out-of Trend investigations
Common pitfalls during OOS Investigations
Review of recent OOS related citations in Warning Letters
Phase I- Laboratory Phase of Investigations
Phase II a Full Scale Investigation
Concluding an Investigation
Out-of Trend investigations
Common pitfalls during OOS Investigations
Review of recent OOS related citations in Warning Letters
Other CFPs
- Supplier Management with the new Medical Device Regulation EU MDR 745/2017
- BSA/AML Contextual Awareness of High Risk Customers
- How to Conduct Successful Supplier Audits
- 21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
- Data Integrity Compliance for Computer Systems Regulated by FDA
Last modified: 2020-10-05 16:36:46