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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.
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.