Lauren Schrader
Transperfect LifeSciences, USA
Title: TMF Inspection Readiness Essentials: Understanding Expectations, Mapping Document Lifecycles, and Reducing Risks
Biography
Biography: Lauren Schrader
Abstract
Risks abound for organizations lacking strategy for managing their Trial Master File (TMF). These risks create delays in timelines and can lead inspection findings. Attendees will have the opportunity to define and discuss potential risks that may affect their inspection readiness. In addition, global regulatory agencies have expectations that must be well understood before beginning to manage a TMF. The workshop will provide attendees with an overview of expectations to make informed decisions on risk-management.
TMF documentation has a lifecycle and that lifecycle tells a story to regulatory bodies inspecting your TMF. Being prepared to tell your story is really what inspection readiness is all about. Knowing where your documents originated from to where they are filed is key. One way companies are able to prepare is to create a map of their TMF. During the workshop, attendees will participate in creating a TMF map that will give them practical knowledge to share with their teams and include in their inspection readiness plans. Such processes are essential to engage in from the beginning of a study. Organizations must at least allow themselves 6-9 months prior to submission to prep, but the best approach is to commit to preparations as part of ongoing operations.
After learning about expectation and some practical methods for inspection readiness, the workshop will take a look at how to avoid some common inspection findings.