Head of TMF Operations
10:30 AM Course Introduction and Welcome
10:45 AM GCP Inspection Overview
This interactive session examines the regulatory and legal framework around inspections, the regulatory bodies involved, and when and how an inspection might occur.
11:45 AM Preparing for Inspections
This section covers what to do from a Records Management perspective to prepare for an inspection. The session includes how to make sure the files are up to date and of good quality, and to how to make the files available to the inspectors. It also covers the types of responsibilities a Records Manager or Archivist may have in an Inspection Readiness Plan (IRP).
Learn what needs to be in place long before an inspection notification is received. This section looks at robust information governance and training, defined Records Management responsibilities, system validation and more. When good processes are in place a company can be ‘inspection ready’ at all times and avoid the time and cost resources associated with last minute inspection readiness planning.
1:45 PM Inspectors Expectations
Learn what issues Inspectors are looking for, the techniques used to find these issues and what Inspectors expect from interviewees. This session also looks at Investigators expectations of electronic versus paper files.
2:15 PM Common Inspection Findings
This session covers the types of inspection findings and the possible impact of these findings. Actual findings and potential future findings based on current trends will be discussed.
This session covers what to do following an inspection or audit. Consideration will be given to the evaluation of CAPAs (Corrective Actions, Preventative Actions) and findings, response prioritisation, and the formulation of strategies to improve compliance. Real-life examples will be used to provide a “lessons learned” experience and provide an opportunity to improve practices and enhance inspection readiness.
3:15 PM Course Summary
Review the salient points from the workshop and share feedback on key takeaways from the day
- Hear how the new TMF management tool gives guidance on managing TMFs throughout a study
-Determine the different factors that need continuous consideration
-Predict how future technologies and eTMF platforms will change the way we prepare for inspection