The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: November 16, 2017 at 9am to November 17, 2017 at 6pm
Location: Boston, MA
Street: Boston, MA
City/Town: Boston, MA
Website or Map: http://www.globalcompliancepa…
Event Type: online, healthcare, training, courses
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Sep 27, 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.
Location: Boston, MA Date: November 16th & 17th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON, Boston, MA
Price: $1,295.00 (Seminar Fee for One Delegate)
Register for 5 attendees Price: $3,885.00
$6,475.00 You Save: $2,590.00 (40%)*
Register now and save $200. (Early Bird)
Until September 30, Early Bird Price: $1,295.00 From October 01 to November 14, Regular Price: $1,495.00
Register for 10 attendees Price: $7,122.00
$12,950.00 You Save: $5,828.00 (45%)*
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