Topic Category: Product Manufacturing

Lecture – Richard Rapoza, PhD, Abbott Vascular

Richard Rapoza, PhD Division VP of Research & Development, Abbot Vascular Learning Objectives Understand the important of anatomy and physiology during the design of the device Understand risk assessment and risk mitigation Learn about sterility, shelf life and packaging Learn the animal model for evaluation: acute, sub-acute, sub-chronic and chronic

Lecture – Brad Quinn, FDA

Brad Quinn Acting Branch Chief, Cardiac Diagnostics Branch, FDA Learning Objectives Learn the component of design controls Understand design verification Understand design transfer Understand design validation Learn small scale manufacturing Understand Scalability

Learning Objectives