Protecting patients, data and reputations
“Protecting patients, data and reputations” training held by RAY through an international speaker for a full 3 days; an interactive workshop covers many topics including: Policy decisions for inspectors, Hospitality, FCPA and ABAC; Inspection logistics, Preparation, including dossier request, TMF review, Selecting studies and sites for inspection, Inspecting computerized systems, Conducting interviews, Inspecting monitoring, Inspecting project management, Inspecting the QMS (SOPs, training, QA), Giving feedback, including exit meeting, Possible problems, Reporting, including writing and classifying findings, Responses – what to accept, when to ask for more.