Laboratory Investigations for Out of Specification Results 2018 is a webinar dedicated to laboratory investigations of out of trend results and also explore approaches which may have potential for pitfalls.
Laboratory Investigations for Out of Specification Results 2018 covers topics such as:
- 21 CFR 210 & 211 requirements for investigations
- ICH guidelines for investigations
- Initiation of an investigation
- Relevant investigational tools
- Finding acceptable resolution
- Controlling the scope of an investigation
- Root causes
- CAPA
Laboratory Investigations for Out of Specification Results 2018 is intended for:
- QC testing groups
- QC functions in general
- Development groups investigating assay failures
- QC investigation groups
- QA reviewers and investigators