Live Online Training: Effective Equipment Qualification according to Annex 15
Im Auftrag der ECA Academy

A team of pharmaceutical companies, engineering companies and suppliers have developed ECA´s Integrated Qualification and Validation Guide over 3 years. Since autumn 2020 the version 1.0 is available. The key for a successful 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 retesting. This is one of the core concepts in the guide . With this course the practical “how to do” will be explained with “real-life” case studies.

Almost 30 years after the coming into force oft he 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 extend the time limits again.  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 fast-track projects. How can this come together? This is the content of ECA´s Integrated Qualification and Validation Guide.

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.