Governance and Change Control According to GxP/GMP Requirements

Course "Governance and Change Control According to GxP/GMP Requirements " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview:- GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. Documentation is a critical tool for ensuring GxP/GMP compliance. In order to maintain documentation in GxP/GMP compliant manner, information governance should be developed and implemented. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. In the regulated industries, manufactures are required to use a change control procedure.
Data security is the high priority in any organization but especially in a regulated industry. E-Discovery preparedness makes it imperative for organizations to develop an enterprise wide strategy to manage the volume of electronic information. The discovery process affects many individuals in an organization, not just lawyers and others involved in discovery, but also IT professionals and records managers who have to be prepared to produce electronic content for discovery and litigation. Crisis preparedness is the high priority in any organization but especially in a regulated industry. With all systems in place, change management and user adoption become necessary. In this seminar, you will learn the framework of GxP/GMP regulations, information governance procedures as well change control procedure and how to implement them. You will also learn how to implement data security, e-discovery and crisis preparedness as well as change management and user adoption strategies.