Lean Equipment Qualification - Online Training Recording

A team out of pharmaceutical companies, engineering companies and suppliers have developed ECA´s Integrated Qualification and Validation Good Practice Guide (GPG) over 4 years. Version 2.2 is published in autumn 2022. The key for a successful equipment qualification project is the “hand-in-hand” work from suppliers and customers together.  With the integration of Good Engineering Practice (GEP) into qualification activities GEP-tests can be used also for the qualification phases – without repeated testing.  This is one of the core concepts in the guide and benefit for the industry. With this course the practical “how to do” will be explained with “real-life” case studies.

Thirty years after the coming into force of the EU GMP Guide in 1992 equipment qualification is still often a miracle. Qualification projects overrun scheduled time limits. Failures are discovered in the IQ and OQ exercises. To fix this and the deviation reports the time limits again have been extended.  A non-harmonized terminology causes one of the main problems, especially when it comes to the integration of good engineering practice into qualification. But on the other side is the integration of good engineering practice activities a key factor for qualification in fast-track projects. How can this come together? This is the content of ECA´s Integrated Qualification and Validation Guide.