16 November 2017, Hilton Copenhagen Airport
5th annual Nordic QAforumThe largest QA-conference in the Nordics.
5 national agenciesGet insights from the authorities from Sweden, Denmark, Norway, Finland & Iceland.
Case studies & discussionsGet best practices from your industry colleagues.
Speakers at Nordic Qaforum 2017:
– Obligations for different stakeholders
– Functionality of the national systems and the EU Hub
– Implementation – who is doing what?
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?
QA management of Supply Chain:
Process Controlled Distribution (incl cold chain management)
GDP/GMP – Which are the most common deviations?
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
How we expect pharmaceutical manufacturers and wholesale distributors to work to prevent and detect fraud – both proactive and reactive in production and distribution
– Authority exemples from audits
Annex 1 – Practical implementation
– A Regulator’s Advice to Ensuring Compliance
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