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Validity : 15th Apr'24 to 25th Apr'24
FDA Compliance and Mobile Applications
- 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
- Q&A
Overview of the webinar
We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order 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
- QC/QA managers and analysts
- Clinical data managers and scientists
- Compliance managers
- Lab managers
- Automation analysts
- Computer system validation specialists
- GMP training specialists
- Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
- Consultants working in the life sciences industry who are involved in computer 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 any mobile application that is part of a system 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. As technology has continued to evolve, including the usage of mobile applications, we encounter new challenges that must be met.
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.