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