Annex 16 (Certification by a Qualified Person and Batch Release) of the EU GMP Guide describes the "handling of unexpected deviations". A batch with an unexpected deviation concerning the manufacturing process may be certified if the result of a risk analysis performed shows that "the potential impact of the deviation on quality, safety or efficacy of the batch(es) concerned and conclusion that the impact is negligible." This flexibility might sound reasonable but puts a lot of responsibility on the QPs. There will always be borderline cases and ambiguities.
Target Group
This Webinar has been designed for EU Qualified Persons (QP) but also QA personnel, upper management functions and other interested people who want to be informed about QP challenges when certifying batches.
Technical Requirements
For our 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 email 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.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF