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.
Objectives of the Presentation
Why Should you Attend
- Upon completion of this session, attendees will have an understanding of how to apply the CSV and SDLC methodologies to computer system validation in support of clinical trial work, and develop a sound strategy for meeting FDA compliance, both one-time and on an ongoing basis.
- The attendees will understand the level of effort required for executing each phase of the CSV/SDLC approach, and the appropriate level of documentation that must be completed to support it. They will also gain an understanding of the training and skills required to apply the CSV/SDLC approach to clinical trial systems when validating or maintaining them.
- The attendees will have a good grasp of how to leverage these practices across all systems by creating a standardized program for applying the SDLC to systems in accordance with FDA requirements.
You should attend this webinar 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.
Who can Benefit
- Gain an understanding of the Computer System Validation (CSV) and System Development Life Cycle (SDLC) Methodologies and how they are integrated
- 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 progresses 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
Information technology analysts, clinical data managers and scientists, biostatisticians, compliance managers, lab managers, automation analysts, computer system validation specialists, GMP training specialists, business stakeholders and individuals who are responsible for validation planning, execution, reporting, compliance, maintenance and audit of computer systems supporting clinical trial work. This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance for clinical trial systems.