24 - 25 September, 2019 | Brussels, Belgium

Eldin Rammell

Managing Director
Rammell Consulting

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 that need to be covered in an Inspection Readiness Plan (IRP)

12:15 PM The Secret to Stress Free Inspections

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

3:15 PM Summary

Review the salient points from the workshop and share feedback on key takeaways from the day

9:50 AM Corrective and Preventative Actions (CAPA) Best Practice

  • Look at what strategies to take when an inspector finds problems you didn’t think were there
  • Understand how to focus on process improvement and increased bandwidth
  • Better identify problems with detailed root cause analysis to remediate legacy corrective actions and support ongoing corrective actions
  • Ensure future success and create a sustainable solution with improved sampling plans, more complete root cause analysis, and CAPA management

Check out the incredible speaker line-up to see who will be joining Eldin.

Download The Latest Agenda