Attendee will be provided an overview of what a TMF is and will contribute to discussions regarding what makes it up and why, who creates it and where it is located, how it is checked for completeness, and how it is audited/inspected. The TMF Reference Model and how it is used to define and organize the TMF will be reviewed. A discussion of the processes that outline the management of the TMF will be included, as well as whether risk-based approaches can be taken while still maintaining a level of confidence of its timeliness and inspection-readiness.
