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Validity : 14th Apr'24 to 24th Apr'24
Clinical Trial Systems and Computer System Validation
- Gain an understanding of the Computer System Validation (CSV) and System Development Life Cycle (SDLC) Methodologies and how they are integrated and applied in validating a clinical trial system
- Understand the best practices for maintaining a computer system in a validated state
- Discuss the best practices necessary to ensure systems supporting clinical trial work are validated appropriately
- Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risks, as clinical trial work can be extremely expensive
- Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization and how they are maintained in a validated state
- Learn how to gain information about trends in validation, as industry progress and new best practices emerge
- Learn about an assortment of computer system types that are used to manage clinical trials (data collection, analysis, reporting, statistics, trending, etc.)
- Understand some of the key “pitfalls” to avoid when applying the CSV and SDLC methodologies
- Q&A
Overview of the webinar
This webinar will help you understand in detail the requirements for validating a computer system that is used in support of conducting clinical trials in compliance with FDA’s Good Clinical Practices (GCP). The approach is based on standard Computer System Validation (CSV) and System Development Life Cycle (SDLC) Methodologies, which employ an approach critical to FDA compliance. It is important to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.
Who should attend?
- Information technology analysts
- Clinical data managers and scientists
- Compliance managers
- Computer system validation specialists
- GMP training specialists
- Business stakeholders and individuals who are responsible for clinical system validation planning, execution, reporting, compliance, and audit
- Consultants working in the life sciences industry who are involved in clinical system implementation, validation and compliance
Why should you attend?
You should attend this seminar if you are responsible for planning, executing or managing the implementation of a computer system that is used to support clinical trial work and is governed by FDA regulations, or if you are maintaining or supporting such a system.
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance. There is an enormous body of documentation and information available that can be overwhelming.
This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.
Faculty - Ms.Carolyn Troiano
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.