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Validity : 01st Oct'24 to 11th Oct'24
FDA Compliance and Laboratory Computer System Validation
- Gain an understanding of laboratory system computer validation planning, execution and management concepts
- Best practices for laboratory computer system validation that will ensure compliant results while minimizing costs
- Identify the GAMP 5 category for the system to understand how best to approach validation, particularly testing
- Discuss the key documentation associated with validating laboratory systems and maintaining them in a validated state, while minimizing costs
- Learn how to leverage these practices across all systems by creating a standardized program for FDA-regulated systems
- Understand the training that must be provided to business and IT staff involved in the validation process
- Discuss the business process re-engineering opportunities that might be leveraged as a system is implemented, particularly if it is more advanced than the legacy system in terms of technology and functionality
- Learn the advantage of incorporating a formal organizational change management system into the validation effort to ensure that users fully embrace the new technology and functionality
- Q&A
Overview of the webinar
Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.
Who should attend?
This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, quality control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. This includes:
- Information Technology Analysts
- Information Technology Developers and Testers
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
Why should you attend?
This webinar will benefit those responsible for planning, executing or managing the validation of laboratory computer systems governed by FDA regulations. Effective and compliant computer system validation is critical to any FDA-regulated organization. During the past 30 years, best practices have been developed that, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.
There is an enormous body of documentation and information available on computer system validation, which can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available. It will assist those responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.
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.