Explore the application of the IEC 62304 standard to medical device software, while uncovering industry best practices for delivering reliable and secure software solutions for medical devices. Designed for professionals in FDA-regulated industries such as pharmaceuticals, medical devices, biologics, animal health, and tobacco, this webinar covers a wide range of relevant functions. Whether you work in research and development, manufacturing, quality control, distribution, clinical testing, management, adverse events management, or post-marketing surveillance, this session is tailored to your needs.
Attending this webinar is essential if you play a role in planning, executing, or managing the implementation of systems governed by FDA regulations. It is equally beneficial for individuals responsible for the maintenance or support of such systems. Stay ahead of compliance requirements, enhance your understanding of industry standards, and ensure the seamless operation of FDA-regulated systems by joining this highly informative session.
Attending this webinar is essential if you play a role in planning, executing, or managing the implementation of systems governed by FDA regulations. It is equally beneficial for individuals responsible for the maintenance or support of such systems. Stay ahead of compliance requirements, enhance your understanding of industry standards, and ensure the seamless operation of FDA-regulated systems by joining this highly informative session.
Agenda
- Providing safe and effective medical devices is in the best interests of all those involved in developing software for these products, and for those involved in developing medical devices that use software
- This session will provide insight into the IEC 62304 standard as it is applied to medical device software
- You will learn how to apply this standard to your own work processes
- You will also gain insight into the current industry best practices that will help you with IEC 62304 compliance
Speaker
Carolyn Troiano has more than 30 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.
