A Risk Based Approach To IT Infrastructure Qualification & Compliance Seminar
Presented by Global Compliance Panel
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. Course DescriptionDate: May 24th & 25th, 2018 Time: 9:00 AM to 6:00 PM Address:Embassy Suites Minneapolis - Airport 7901 34th Avenue South, Bloomington, MN 55425, USA Price: Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird) Until April 10, Early Bird Price: $1,295.00 From April 11 to May 22, Regular Price: $1,495.00
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.
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. The Seminar:This Seminar provide a risk based approach to meeting current regulatory expectations for compliant IT Infrastructure platforms, including the need to identify, qualify and control those aspects impacted by GxP quality and data integrity. It provides current best practices for the design, qualification and operation of an IT Infrastructure with emphasis on the qualification requirements of the major components. It addresses compliance with international GxP regulations and can be used both for the establishment of new platforms and extensions or existing platforms whether or not they are currently in support of GxP applications. Finally, this seminar covers a range of IT Infrastructures, from those found in companies operating in a global setting to isolated or semi-isolated GxP Infrastructures. This Seminar focuses on the horizontal approach to IT Infrastructure Qualification which includes the following benefits:
Why you should attend:
Industries:
Agenda: Day 1 ScheduleLecture 1: Introduction and Background
Lecture 2: Quality Management
Lecture 3: Risk Management
Lecture 4: Qualification of Platforms
Day 2 ScheduleLecture 5: Qualification of Platforms (cont'd)
Lecture 6: Operations
Lecture 7: Operations (cont'd)
Lecture 8: Maintaining the Qualified State
Quiz: Jeopardy!!!!
Angela BazigosCEO, Touchstone Technologies Silicon Valley
Credits AvailableCourse "A Risk Based Approach To IT Infrastructure & Cloud Qualification, Compliance & Control" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion
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