Webinar
Do you understand how risk management strategy impacts design controls? Join Dr. Stephen Coulter as he presents an in-depth overview of the Waterfall design model and addresses the question, Are Risk Management and Design Controls two different processes? You’ll learn more about incorporating risk management strategies into user needs and design inputs, as well as how validating both will accelerate the success of your design review process.
General Manager & Subject Matter Expert
Dr. Stephen Coulter is the General Manager and Subject Matter for Nelson Labs company Regulatory Compliance Associates (RCA), bringing over 40 years of experience to his role. His areas of expertise include product development, design control, design transfer to manufacturing, technology partnerships, product lifecycle management, portfolio management and acquisition analysis. Steve’s regulatory affairs and quality assurance experience includes preparation of design history files or technical files for regulatory submissions. He has also participated in company advocacy efforts with federal agencies, congressional personnel, and public health groups.
