Writing an investigation report is sometimes viewed as a “penalty” when something doesn’t go as planned or when an unwanted – or unforeseen – event occurs. From a quality perspective, these reports have the potential to contribute to product and process understanding and help prevent recurrences from occurring in the future.
This course is aimed at those who write, review, and approve incident and deviation investigation reports for laboratory, operations, and other GMP areas. The course identifies what national authorities and quality auditors are looking for in reports and provides a structured approach for doing investigations, identifying Corrective Actions and Preventive Actions (CAPAs), and writing sections of reports that are defendable, yet clear and concise.
The course includes activities where participants evaluate investigation reports and identify ways to improve them. The final activity is for participants to write an investigation report based on different case studies.
Provide participants a model for a well-written investigation report and enhance their skills at writing and reviewing such reports.
Operations, laboratory, technical, and quality personnel who write, review, approve, or contribute to incident, deviation, OOS or CAPA investigation reports.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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