14 November 2019, Clarion Copenhagen Airport
7th annual Nordic QAforum
The largest QA-conference in the Nordics.
5 national agencies
Get insights from the authorities from Sweden, Denmark, Iceland, Norway and Finland.
Case studies & discussions
Get best practices from your industry colleagues.
Speakers at Nordic Qaforum 2019:
How to survive an authority inspection – 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).
Data Integrity and Computerised Systems – recent deficiencies in inspections
GDP/GMP – the most common deviations
Serialization – how we will inspect
– What to expect from the authorities regarding supervision of serialization
9 months after 9th of February- current status in Europe
– On-boarding to Eu Hub
– How to manage a “potential suspect falsification”
– Alert status & alert handling process
FMD Implementation – Best practices from AstraZeneca
Roland is the QA Lead for FMD implementation globally for AstraZeneca. 13 sites around the world were involved in the process. 2000 articles were affected by FMD.
Serialization in Norway – actual status from the Medicines Agency