18 November 2021, Clarion Copenhagen Airport
8th annual Nordic QAforum
The largest QA-conference in the Nordics.
National agencies
Get insights from the authorities from Sweden, Iceland, Denmark, Norway and Finland.
Case studies & discussions
Get best practices from your industry colleagues.
Speakers at Nordic Qaforum 2020:
21 months with FMD – current status in Europe
– Alert management – real cases and investigations. What happens when the system identifies a potential falsification?
– Alert management around Europe. Similarities and differences. Could there be one alert management process for whole Europe?
– Change management for a pan-european system. How do you handle change management for one eco-system with 30 systems owners?
Q&A
– Ask your questions to Norwegian Medicines Agency
How to survive an authority inspection 2021 – a practical guide
Before joining Danish Medicines Agency in 2013, Thomas worked for 12 years as a manager/director at the Danish pharmaceutical company Statens Serum Institute (now AJ Vaccines).
GxP Inspections during Covid19 pandemic – adapting to a new reality
Monitoring the quality of COVID-19 test kits with real-time visibility technology
Drawing from an actual example demonstrating how real-time monitoring has helped Ipsos MORI monitor location and quality conditions of tens of thousands COVID-19 test kits throughout the UK, attendees will take away a better understanding of and actionable insights into:
– How real-time visibility has helped ensure quality and mitigate supply chain risk
– How technology is automating the quality control and release process
– How stakeholder collaboration and data sharing is key to achieving supply chain resilience
– What the post-pandemic supply chain will look like
Speaks with Anna Beckman Gyllenstrand
Inspections – what you can expect from us
– What to expect regarding supervision of serialization
– GDP/GMP – the most common deviations
– Deviations & findings that surprised us
Annex 1 – How will it affect you
– Deviations & findings that surprised us
Speaks together with Kelly Beaver
