Date :
Place : United States, las vegas, nv
Contact Person:Event Manager
Description:
Course "A Risk Based Approach To IT Infrastructure Qualification & Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance. The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance. Effective IT Infrastructure Qualification on the other hand, confers the following benefits. • Ensures GxP compliance • Reduces duplication of effort • Ensures adherence to standards • Enhances the flow of information throughout an information system • Promotes adaptability and agility necessary for a changeable environment • Ensures interoperability among organizational and external entities • Maintains effective change management policies and practices Although all business activities depend upon the infrastructure, planning and projects to ensure its effective management are typically undervalued to the detriment of the organization. According to IDC, a prominent research firm (cited in an article in DM Review), investments in infrastructure management have the largest single impact on an organization's revenue. Establishment and maintenance of a controlled infrastructure requires that infrastructure needs to be brought into initial compliance with the company's established standards, through a planned qualification process, based upon domestic and international best practices and standards. The qualification needs to be documented and confirmed by Quality Assurance. Once the IT Infrastructure is qualified, the compliant state needs to be maintained by documented standard processes and quality assurance activities. The effectiveness of maintaining the qualified state needs to be monitored and periodically verified.Deadline for abstracts/proposals : 14th March 2018
Organized By :NetZealous DBA as GlobalCompliancePanel
Keynote Speakers : Angela Bazigos CEO, Touchstone Technologies Silicon Valley Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech &
Conference Highlights :Pharmaceuticals Biotech Medical Device Radiological Health Blood Products Companion Animals Food Cosmetics Tobacco Academia
Venue :Las Vegas, NV, United States
Check the event website for more details.