GCP Regulatory Inspection Readiness Training Day
10:30 am - 10:45 am Course Introduction and WelcomeJamie Toth - Head of TMF Operations, Daiichi Sankyo
10:00 am - 10:30 am Welcome Coffee and Registration
10:45 am - 11:15 am GCP Inspection OverviewJamie Toth - Head of TMF Operations, Daiichi Sankyo
This interactive session examines the regulatory and legal framework around inspections, the regulatory bodies involved, and when and how an inspection might occur.
11:15 am - 11:45 am Coffee Break
11:45 am - 12:15 pm Preparing for InspectionsJamie Toth - Head of TMF Operations, Daiichi Sankyo
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).
12:15 pm - 12:45 pm The Secret to Stress Free InspectionsJamie Toth - Head of TMF Operations, Daiichi Sankyo
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.
12:45 pm - 1:45 pm Networking Lunch Break
1:45 pm - 2:15 pm Inspectors ExpectationsJamie Toth - Head of TMF Operations, Daiichi Sankyo
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 - 2:45 pm Common Inspection FindingsJamie Toth - Head of TMF Operations, Daiichi Sankyo
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.
2:45 pm - 3:15 pm Responding to Inspections, Audits and FindingsJamie Toth - Head of TMF Operations, Daiichi Sankyo
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 - 3:30 pm Course SummaryJamie Toth - Head of TMF Operations, Daiichi Sankyo
Review the salient points from the workshop and share feedback on key takeaways from the day
3:30 pm - 4:00 pm Afternoon Coffee Break
4:00 pm - 5:00 pm Afternoon Seminar: Obstacles, Misconceptions and Steps to Avoid Failed TMF Inspections
In this workshop we will look at common documentation inspection trends and most common findings in contents review. Through sharing a series of examples we will look at common misconception of how to prepare a TMF for inspection and pitfalls to avoid.
Attend this session to:- Deep dive into best practices in TMF management
-Understand the tools available to optimise the best approaches in inspection preparedness
-Examine the different points of view and gain clarity on the role of the inspector
5:00 pm - 5:30 pm Networking Drinks Reception
After a day of training and preparing for inspection, relax and unwind with your peers over a drink or two!