Topic: The Ten Most Important Risk Factors to Address in order to Maintain “Real Time” Inspection-Ready TMFs With a career spanning more than two decades, Mrs. Jackson brings a wealth and breadth of knowledge and experience which is highly valued; providing key Regulatory Operations and TMF Management consulting guidance to Regulatory and Clinical Operations departments. Working with large and small pharmaceutical and biotechnology companies has allowed Tamika to develop proven methodologies in any organization required to prepare, submit, manage, track and produce “real-time” inspection ready TMFs and regulatory submissions to ensure agency approval. Tamika, along with her SWAT team of professionals, now work to efficiently and effectively evaluate companies’ resources, processes, documentation, systems, and TMF Management activities to methodically streamline the operation from end-to-end.