Our two-day Level 1 Inspector workshop is designed to prepare participants with the knowledge and experience necessary to conduct effective risk-based six-system audits used by the regulators to detect, document, and communicate deficiencies. In this course, we introduce the trigger-target-finding approach to inspection, which allows the inspector to uncover deficiencies that would not be detected without making connections between related elements from different sources. Participants will learn to develop their own critical thinking checklist so that serious deficiencies within the design, operation, and/or monitoring of a GXP system are not overlooked during an inspection, and develop the confidence necessary to perform comprehensive assessments within a limited timeframe.
Topics addressed in this course include:
Highlights of the six-system approach to inspection
Take-aways from current PIC/s harmonized guidance for inspectors
Connecting elements from unrelated data sets to uncover meaningful observations
Forming observations using the trigger-target-finding approach to inspection
Technical writing for effective communication
ICH Q9 and its application to inspection
Live Oak Level 1 Inspector Certification can be achieved by participating in the optional post-workshop evaluation. Details for Level 1 Inspector Certification will be discussed further during the workshop.