Venue: Hilton Dublin
|Event Date/Time: Jan 24, 2006||End Date/Time: Jan 27, 2006|
|Registration Date: Nov 24, 2005|
|Early Registration Date: Nov 29, 2005|
Change control is a formal monitoring system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status. This is done to determine the need for Corrective Action to ensure that the system retains its validated state. Management and implementation methodologies associated with increasing or correcting system capabilities, a partial system redesign or the determining of software obsolescence. Change control activities and procedures apply to: design, components, including software; labeling and packaging; device manufacturing processes; production equipment; manufacturing material; and all associated documentation such as quality system procedures, standard operating procedures, quality acceptance procedures and data forms, and product specific documentation. Change control should also be applied to any production aids such as labeled photographs and models or samples of assemblies and finished devices.