WEBINAR OVERVIEW

Effective Risk Management is essential to a product's development and post-production success. Now, more than ever, life science companies need strong risk systems in place. This webinar provides insight into these necessary industry standards and offers meaningful techniques that risk management professionals can use to implement ISO 14971 and ICH Q9 into their quality system.

LEARNING OBJECTIVES

• Understand where risk comes from and how to identify the sources
• Overview of common risk management techniques
• Analyze potential problems and follow a proven process to mitigate, control, and document risk
• Build alarms into your analysis that shorten the time to risk containment and reduce damage controls
• How to reduce and prevent future risk occurrence

AUDIENCE

This course is appropriate for the following individuals:

• Research and Design Engineers
• Risk Management professionals
• Quality Assurance professionals
• Regulatory and Compliance professionals

ABOUT THE SPEAKER

Ed Bills has over 25 years experience in quality systems management spanning most life science industries. He is currently a Principal Consultant, providing training, auditing and consulting services in the areas of quality systems, regulatory affairs, and risk management for medical device and pharmaceutical companies.

His past work has included litigation for life science manufacturers, regulatory leadership and product development. As a board member, he helped write and create the current ISO 14917 operating standard for medical device manufacturers. He currently manages and presents training seminars in both the educational and corporate setting in the areas of quality and compliance.