Date: 8 Jun 2016, 8:45 - 11:15
Host: Epista, Slotsmarken 17, 2970 Hørsholm
Get ready for the FDA – and improve overall business processes at the same time
- Are you ready for an FDA inspection?
- What regulations are you subject to?
- How is regulatory compliance handled in other companies?
- Is there synergy between ‘inspection readiness’ and optimizing general business processes?
These are frequently asked questions when it comes to Life Science regulatory compliance. The challenge is to be “in control” of compliance while also balancing risk, quality and cost. The answer is to think pragmatically and get to the ‘just-right’ compliance level.
Industry experts met us to discuss the most efficient way to balance risk, compliance and business goals. We discussed why and how to create an IT Compliance Plan that includes validation of computerized systems, control of legacy systems, qualified IT infrastructure, and take into account new focus by FDA and global regulatory authorities on data integrity. We also discussed the basics of an IT Quality Management System and the value of mock inspections.
This was a unique opportunity to hear from industry experts and practitioners. You hopefully gained valuable insights and operational tips for improving the quality and outcome of your organization’s compliance efforts. It is much cheaper to find the problems yourself, than to have an FDA inspector find them!
Registration and networking
Get a ‘just-right’ compliance level
Mikael Yde, Principal Consultant, Epista
Mikael discussed the most efficient way to balance risk, compliance and business goals. He explored why and how to create an IT Compliance Plan that includes validation of computerised systems, control of legacy systems, qualified IT infrastructure, and take into account new focus by FDA and global regulatory authorities on data integrity. He also discussed the basics of an IT Quality Management System and the value of mock inspections.
Case presentation from Oticon
Ole Markersen, Senior Director, Compliance Projects, Oticon A/S
Ole discussed the role of system owner and its responsibilities. He shared his experience from the compliance program in Oticon: From identifying compliance gaps to the change and implementation of new QMS system; including getting in control of legacy IT systems. He reflected on project governance, its tasks and challenges.
Q&A and Wrap-up