16 November 2017, Hilton Copenhagen Airport

5th annual Nordic QAforum

The largest QA-conference in the Nordics.

4 national agencies

Get insights from the authorities from Sweden, Denmark, Norway and Finland.

Case studies & discussions

Get best practices from your industry colleagues.

Speakers at Nordic Qaforum 2017:

Practical implementation of the Falsified Medicines Directive and Delegated Regulation
– Obligations for different stakeholders
– Functionality of the national systems and the EU Hub
– Implementation – who is doing what?
– What can we learn from the pilots?
Anci Kvarnström

Project leader for the Swedish Implementation & Consultant for EFPIA

The authorities expections on serialization
– Opportunities and challenges with serialisation for a regulatory body
– Lessons learned from the serialization pilots
– Serialization – how we will inspect?

Finnish Medicines Agency

Johanna Linnolahti, Senior Pharmaceutical Inspector

GDP/GMP – Which are the most common deviations?

Swedish Medical Products Agency

Emil Schwan, Inspector GMP/GDP

Audit of suppliers and contract acceptors – when is it necessary and how to do it?
– Supplier qualification according to GDP. Who do we need to qualify and how?
– The difference between being a contract acceptor and being a customer
– GDP-relevant outsourced activities, included transportation
– Authority examples from audits

Norwegian Medicines Agency

Line Saxegaard, Pharmaceutical inspector

Annex 1 – Practical implementation
– A Regulator’s Advice to Ensuring Compliance

Danish Medicines Agency

Kristine Frederiksen, Medicines Inspector

QA management of Supply Chain:
Process Controlled Distribution (incl cold chain management)

Astra Zeneca

Anna Berg, QA Manager, QP

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