The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: January 18, 2018 from 9am to 6pm
Location: San Diego, CA
Street: DoubleTree by Hilton San Diego Downtown
City/Town: 1646 Front St, San Diego, CA 92101, USA
Website or Map: http://www.globalcompliancepa…
Event Type: regulatory, and, compliance, seminars
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Nov 15, 2017
Course "A Risk Based Approach to Testing of Computerized GxP Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11.
"Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered"
The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. The assurance that systems perform as intended for their use reduces the overall lifecycle of implementing and operating the system and prevents delays to the use of the system that might have been caused by the need to make corrections to the system.
Conversely, insufficient or inappropriate testing may cause problems later on in the lifecycle and these problems will be more costly, time consuming and troublesome to resolve. Potential consequences include a system that does not meet intended requirements, a costly program of corrections and increased maintenance and support costs.
Location: San Diego, CA Date: January 18th & 19th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA
Price: $1,295.00 (Seminar Fee for One Delegate)
Register now and save $200. (Early Bird)
Until December 10, Early Bird Price: $1,295.00 From December 11 to January 16, Regular Price: $1,495.00
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%)*
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NetZealous LLC DBA GlobalCompliancePanel
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