Sessions
Recall Readiness Enforcement trends and what CDRH is looking at today
12:15 PM - 1:00 PM Mon
Patterson Shafer has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. His domestic and international regulatory experience includes developing new product regulatory strategies, health authority interactions, submissions/approvals, labeling compliance, 483/Warning Letter/Consent Decree response and remediation program development and execution. He is internationally recognized for his subject matter knowledge and experience concerning regulatory, quality and safety capabilities. He works frequently at the intersection of business and technology, designing and implementing regulatory and quality systems, including eQMS, Regulatory Information Management (RIM), Regulatory Intelligence and AI/machine learning.
Shafer is a strategic advisor to the FDA, having assisted them in various areas, including product quality, patient safety and digital health. For several years, he has been co-leading collaboration efforts among the FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry as part of the FDA’s Case for Quality Prior to joining FTI Consulting, Shafer served in leadership roles at Grant Thornton and Deloitte Consulting.