Event
Course Description:
This course introduces out of specification (OOS) investigations including flow chart phase-Ia, phase-Ib and phase-II. Additionally, regulatory framework and consequences of incomplete OOS investigations (483s, WLs) will be addressed.
Upon completion of this course, you will be able to:
- Identify out of specification (OOS) cases during pharmaceutical laboratory operations
- Describe similarities and differences between USFDA and MHRA guidelines for OOS investigation.
- Explain the various stages of investigation and their importance
Who Should Participate:
- QA Manager
- QA Staff
- QC Chemist
- QC Manager
- Regulatory