The new version of Annex 1 is published, finally!

Key2Compliance has prepared for the publication for a long time and we have webinars, training courses and consultation services ready to support you.

First out is a webinar together with the Danish Medicines Agency on October 11th. After that, we run a number of courses on Annex 1 and related subjects like Contamination Control Strategy and Risk Management. The courses are listed below.

Our experienced consultants can support with any issues arising when you struggle to comply with the new requriements; eg Gap-analyses, CCS-implementation or Risk analyses.

Remember that the deadline for implementation is soon – already by the end of August 2023.

Sign up soon or contact us for more information!

• EU GMP Annex 1 – Highlight of the new industry requirements – Final Annex 1 out now!
• Contamination Control Strategy – An essential requirement of the EU GMP Annex 1
• Introduction to Risk-based thinking and Quality Risk Management
• Effective root cause investigation for the Life Sciences