Description
GDP Change Control – Introduction
The GDP Change Control course is a process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without forethought, introducing faults into the system or undoing changes made by other users of software. The goals of a change control procedure usually include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing change. The whole exercise from implementation through to closure must happen within the scope of the QMS (Quality Management System.)
What’s inside…
The GDP Change Control course will cover the process from justification and impact, differing classifications, action plans, pre-implementation approval, through to QA (Quality Assurance) closure post-implementation. The course also has the statutory “bench mark” pre-test, which is designed to measure where your knowledge and common sense is concerning this subject ahead of the lesson, and of course the post-test assessment which should you pass, supplies you with a pass certificate.
Outcome
The change control procedure is to be executed correctly and in a compliant manner, within the scope of QMS. This course will help staff members, management and RP’s undertake the change control procedure in the right way which will be commensurate to the QMS and related QA (Quality Assurance) and RA (Risk Assessments.)
Who is it for?
The course is for management, RP’s, supervisors and staff members. For further assistance, please visit our Help & Support page on the GDP Training website. Good Distribution Practice guidelines are also available at the European Commission GDP Guidelines ( 2013/C 343/01).
