In this webinar, we will delve into the critical aspects of applying computer system validation to mobile applications subject to FDA regulations. Developing the right validation strategy is crucial to ensure that systems function as intended and are maintained in a validated state throughout their entire life cycle.
We will explore key areas of focus, including security, access, and change control, and discuss the necessary documentation to create a comprehensive and compliant validation package in a cost-effective manner.
The session will concentrate on mobile applications used to process FDA-regulated data, such as data collection, analysis, transfer, and reporting. Mobile applications are relevant across various FDA-regulated company functions, including Quality Laboratories, Manufacturing, Supply Chain/Distribution, Adverse Event Reporting, and Post-Marketing Surveillance, among others.
As technology evolves, it's essential to adapt our approach to computer system validation for FDA-regulated systems, taking into account all necessary controls, whether technical or procedural. Mobile devices introduce additional complexity due to their small size, portability, and vulnerability to both physical and logical mishaps or calculated attacks.
Areas covered in the session:
- Gain an understanding of how mobile applications should be handled when performing validation work
- Understand the best practices for maintaining a mobile application in a validated state
- Discuss the best practices necessary to ensure all systems, including mobile applications, are validated appropriately
- Learn how to develop the appropriate computer validation strategy when dealing with mobile applications to ensure a good balance of cost vs. risk
- Understand how to effectively document the process of computer system validation, and maintain current information about the various systems in your organization, as they begin to include mobile applications
- Learn how to gain information about trends in validation of mobile applications, as industry progresses and new best practices emerge
- Understand some of the key “pitfalls” to avoid when applying the concepts of computer system validation to mobile applications
Why should you attend?
- Attending this webinar will empower you with the knowledge and best practices to effectively navigate the complex landscape of computer system validation for mobile applications subject to FDA regulations.
- You will gain critical insights into maintaining a validated state for mobile applications and developing a robust validation strategy that balances cost and risk.
- This webinar will also equip you with the know-how to document the validation process comprehensively and stay up-to-date with industry trends and emerging best practices.
- By understanding the potential pitfalls in applying computer system validation to mobile applications, you will be better prepared to ensure compliance, enhance security, and optimize the use of mobile applications across various FDA-regulated functional areas within your organization.
Don't miss this
opportunity to enhance your expertise and stay ahead in the rapidly evolving
world of mobile applications and FDA-regulated systems.
What industries will benefit from this training?
Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:
- Pharmaceutical (for drug products introduced using a medical device)
- Medical Device
- Biologicals (for biological products introduced using a medical device)
- Tobacco (based on the Tobacco Control Act of 2009)
- E-Liquid/Vapor (based on the “Deeming” Act of 2016)
- E-Cigarette (based on the “Deeming” Act of 2016)
- Cigar (based on the “Deeming” Act of 2016)
- Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
- Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA
Who will benefit?
Information Technology Analysts
- Information Technology Developers and Testers
- Software Quality Assurance Professionals
- QC/QA Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Regulatory Submissions Specialists
- Risk Management Professionals
- Clinical Data Analysts
- Clinical Data Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
- Vendors responsible for software development, testing and maintenance
- Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
This webinar is specifically tailored to professionals in FDA-regulated industries who are seeking to enhance their knowledge and understanding of computer system validation for mobile applications.
Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation
Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.