A Risk Based Approach to Testing of Computerized GxP Systems 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. Overview: 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 ris... Read more

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. Overview: 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. The Seminar: 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: • How does testing fit into GaMP5 lifecycle • Risk based methodology for testing • How do I leverage supplier testing • What should I test? • How much testing is enough? • How should I conduct the tests • How should I document my testing • How do I maintain the testing integrity of my system • Testing related 483s and Warning Letters • Case Studies Why you should attend: • VP of IT • Director of IT • Quality Managers • Project Managers (for CSV / IT) • Validation Specialists • Database Administrators • System Administrators • Directors / Senior Directors of Discovery • Directors / Senior Directors of Development • Directors / Senior Directors of Commercialization • Document Managers • Training Managers • Regulators Industries: • Pharmaceuticals • Biotech • Medical Device • Radiological Health • Blood Products • Companion Animals • Food • Cosmetics • Tobacco • Academia Agenda: Day 1 Schedule Lecture 1: Introduction and Background • Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss) • Introduction to Testing • GaMP5 Key Concepts • Risk Management Methodology Lecture 2: Leveraging the Suppliers' Work • Supplier Assessment • Leveraging Supplier Testing • Determining Appropriate Test Evidence • What to do if the supplier does not meet testing requirements Lecture 3: Test Planning & Management • Types of Testing • Test Policies & Level of Testing • Non-Linear S/W Development (e.g. Agile) • Test Plan or Strategy • Test Specifications, Cases & Scripts • Testing Environments Lecture 4: Test Execution & System Handover • Test Pre-Requisites • Manual Test Execution • Automated Test Execution • Test Results Recording & Reviewing • Test Reporting & System Handover Day 2 Schedule Lecture 5: Operational Phase Testing • Change Control • Test Environments • Change Implementation / Approval / Rollback Lecture 6: Data Migration Testing • Data Migration Principles • Manual Data Migration • Automated Data Migration • Data Migration Verification • Change Control for Data Migration Lecture 7: Case Studies - Part 1 • Testing Configurable IT Systems • Testing Spreadsheets and End-User Developed Applications • Testing of Cloud Applications • Testing Analytical Instruments Lecture 8: Case Studies - Part 2 • Testing of Infrastructure & Interfaces • Testing Process Control Systems • Testing Packaged Systems • Testing Systems Applying Process Analytical Technology Quiz: Jeopardy!!!! • Testing GxP Computerized Systems Speaker 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 & 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: Boston, MA Date: November 16th & 17th, 2017 and Time: 9:00 AM to 6:00 PM Venue: WILL BE ANNOUNCED SOON, Boston, MA Price: 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%)* 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. For More Information- https://www.globalcompliancepanel.com/control/sponsorship Contact us today! 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