Change Control - New Aspects and Best Practices 26-27 February 2009 Prague, Czech Republic Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1590,--) Book this option: ECA Members (EUR 1431,--) Book this option: EU GMP Inspectorates (EUR 795,--) Book this option: APIC Members (does not include ECA membership) (EUR 1510,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives During this course, you will learn all relevant aspects to implement and/ or improve your Change Control System which fulfils current and future regulatory GMP requirements. You will get to know the whole process from initiation over implementation to regulatory submissions. Change control systems should be an integral part of the quality management system of each company. Their task and aim is to ensure that all announced or requested changes are carefully checked and completely documented and authorised. Background Before starting implementing the change, many question need to be answered like: How is the change classified Is it a variation or a change Who needs to be informed What are the regulatory consequences A sound change control system is used to manage changes of all types. The Change Control process is necessary to prevent inappropriate changes from occurring. All GMP-relevant changes should only be made with a complete review and approval of the QA and any other department that might be impacted by the change. Only if all functions involved in the process are working together and know what needs to be considered, the change control process will run smoothly and fast enough to benefit from the change. It is of high importance to know all relevant aspects of the whole change control process and the consequences a change might have.