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).

Danish Medicines Agency

Thomas Noe Vestergaard Pedersen , Medicines Inspector & Team Manager

Data Integrity and Computerised Systems – recent deficiencies in inspections

Finnish Medicines Agency

Mirka Laavola , Senior Pharmaceutical Inspector

GDP/GMP – the most common deviations

Icelandic Medicines Agency

Jon Petur Gudmundsson, Inspector

Serialization – how we will inspect
– What to expect from the authorities regarding supervision of serialization

Swedish Medical Products Agency

Emil Schwan, Inspector GMP/GDP

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

e-VIS

Kristina von Sydow, CEO

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.

AstraZeneca

Roland Gustafsson, QA Director, QP

Serialization in Norway – actual status from the Medicines Agency

Norwegian Medicines Agency

Line Saxegaard, Pharmaceutical inspector

Early Bird - Register before 20th of aug