Event
This four hour course provides an overview of deviations,
regulatory guidelines, Investigation plans, root cause analysis (RCA) tools and
an overview of CAPA will also be covered.
Upon completion of this course, you will be able to:
- Demonstrate knowledge of root cause analysis tools and their application for investigation of OOS and deviation through structured exercises and case studies.
- Explain the regulatory repercussions of incomplete deviation investigations (483's, WL)
Who Should Participate:New recruits in he industry with at least 1 year of experience including:
- Analytical scientist
- QA/QC analysts
- R&D scientists, manager
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract manufacturing organizations