The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them. This session will provide insight into the IEC 62304 standard as it is applied to medical device software. You will learn about industry best practices for the delivery of reliable and safe software for medical devices.
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.
You should attend this webinar if you are 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.
Areas Covered in the Session :
- 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
Who Should Attend:
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Analytical Chemists
- Quality Managers, Chemists, and Microbiologists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Automation Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns working at the companies listed above
- This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
Course Director: CAROLYN TROIANO
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.