16 - 19 September, 2019 | Pullman Brussels Centre Midi Hotel, Brussels, Belgium
Elke Ufer, Global GxP QMS Manager, Global Quality Assurance at Grünenthal
Grünenthal Logo

Elke Ufer


Global GxP QMS Manager, Global Quality Assurance
Grünenthal

Main Conference Day 2

Wednesday, September 18th, 2019


10:15 AM Case Study: Implementation of a New Global QMS in a Mid-Size Company and Lessons Learned

  • Define the steps that must be implemented before the new QMS goes live and how to achieve them
  • Analyse the compliance risk of implementing a new QMS and what to consider for inspection readiness
  • Reflect as Grunethal guides you through their experience following implementation and consider lessons learned

Post-Conference Mock Inspection

Thursday, September 19th, 0019


9:30 AM All–Day Mock Inspection Workshop

Introduction:
Complete your journey by putting your new skills to the test in this mock inspection workshop. Join Grünenthal and Roche as they guide you through their most recent inspections, including preparatory and follow-up activities. By engaging in interactive break-out sessions and real life case studies, will you go home with the confidence, you ARE inspection ready.
 
Session Objectives:
  • Develop a deeper understanding of what efforts must be taken before a mock inspection
  • Design strategies on how you can plan your own mock inspection
  • Understand the benefits and pitfalls of a mock inspection
  • Analyse what an inspection could mean for our company or study site
  • Define the similarities and differences of a sponsor and site inspection
 
Key-Take Homes:
  • Understand how to effectively prepare for a mock inspection, including back office organisation
  • Discover the importance of mock-interviews and learn how you can train potential interviewees
  • Learn how to turn a tricky inspection around by understanding how you can adapt during your inspection
  • Enforce lasting change by successfully implanting follow-up activities
  • Clarify the differences between a mock inspection and a real one

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

Download The Latest Agenda