Lea Joos, GMP-Inspectorate, Local Government Munich, Germany
Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and procedures in place to deal with such situations. When an unplanned event arises it must be handled accordingly.
In any case a sound failure investigation is the key to identify appropriate CAPAs. Here it is also important to know how to deal with human error based and non-human error based non-conformances.
Independent from that, it needs to be pointed out that CAPA is an excellent Quality Management tool to continuously improve processes and avoid future failures.
ECA has now set up a series of four Webinars to discuss principles and relevant aspects to implement, improve and monitor your Deviation Management and CAPA System.
This series of webinars is designed for all personnel involved in Deviation Management and CAPA activities at their company. It is addressed to persons from Quality Assurance and Control, Manufacturing and R&D.
Each webinar can also be attended as single Event.
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.
During the Webinar on Regulatory Background, Principles, Expectations of the Inspectorates we will talk about:
- International Requirements – Rules and Regulations
- GMP requirements
- What to do
- Deviations in the Light of Inspections
- Examples from the real GMP-world
- Most frequently detected issues