Why Should You Attend:
This webinar will cover FDA’s expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work. Attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
All types of clinical trial systems will be discussed, including in-house developed code, configurable systems and custom designed systems. Best industry practices and potential pitfalls in validating clinical trial systems, along with examples, will be covered in detail.
Ongoing maintenance of the system in a validated state will be discussed, as well as governance, archival and retirement.
The webinar will also discuss the importance of applying good project management, business process re-engineering and organizational change management principles through the validation process and beyond.
Learning Objectives: Upon completing this course participants should:
Areas Covered in the Webinar: This course includes the following key areas of learning:
Who Will Benefit:
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management and post-marketing surveillance.
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.Instructor Profile:
Carolyn Troiano has more than 30 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.
The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Rule, known as “Good Clinical Practices,” or simply, “GCPs.”
Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA’s guidance on computer system validation. This involves a rigorous set of phases and steps to ensure that, in the language of FDA, “a system does what it purports to do.”
The cost of adequately validating a clinical trial computer system can be high, and must be weighed against system risk and usage. GAMP 5 system classification guidelines can help ensure that a clinical trial system is categorized appropriately, based on the type of system and technology involved. Along with risk, system classification can provide a clear-cut pathway for validating a system, based on the appropriate level of testing and validation effort.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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