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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.
Additionally, failure to appropriately test functions that have high impact on patient safety, product quality and/ or data integrity, may undermine the compliance and fitness for intended use of the system. Inadequate testing may lead to regulatory citations and possibly further regulatory action, damaging business credibility, reputation and potential for revenue.
The number and types of tests should be based on risk, complexity and novelty of the software. Testing should confirm that system specifications have been met. This may involve multiple stages of review and testing depending on the type of system, the development method applied and the use of computerized system. Regulated companies should be prepared to justify the adequacy of their testing approach.
A science quality management system such as ICH Q9 should be used to determine the appropriate level of verification and documentation. Tests should be designed to demonstrate that all required risk controls are in place. Proposed changes to the system should trigger an impact analysis to determine the extent of any reverification, including any regression testing required. Alterations to the system should be made only in accordance with a predefined change control procedure. Such change control procedures need to include provision for proposing, approving and / or backing out of the change.
This seminar provides attendees with hands-on guidance on the testing of computerized and software systems that impact patient safety, product quality and data integrity. It will identify the testing that should be performed and the associated level of documentation. The areas covered are:
Why you should attend:
Day 1 Schedule
Introduction and Background
Leveraging the Suppliers' Work
Test Planning & Management
Test Execution & System Handover
Day 2 Schedule
Operational Phase Testing
Data Migration Testing
Case Studies - Part 1
Case Studies - Part 2
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 & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.
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)
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Until December 10, Early Bird Price: $1,295.00 From December 11 to January 16, Regular Price: $1,495.00
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Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
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