Anna Lundén

Anna Lundén is Director, Strategic development Pharma and part owner in Key2Compliance AB. She works in close contact with the industry with both training and consultancy and has developed various training modules for many different levels of employees, from top management to line operators. She has long experience of working with European companies dealing with FDA requirements and expectations.

Prior to founding Key2Compliance AB (former Lundén/Ellow ab) in 1995, she worked for 13 years with the Nordic distributor of Pall Europe Ltd and gained extensive from both development projects and process applications within the industry.

She is the author of “The GMP Handbook” and “Quality System Handbook for Medical Device” , has participated in the development of Play4GMP®, the GMP training boardgame and Gate2GMP®, a search tool for compliance information. She has also developed a unique training concepts for interactive classroom training for operators, “The GMP Game”, “The GMP Challenge” and “The Dirty Dozen for Life Science”.

Anna also participated in the development of the third edition of AAMI* “The Quality System Compendium – CGMP Requirements and Industry Practice”.

*The Association for the Advancement of Medical Instrumentation