097 - Predictive Quality, Business Process Capabilities, 3 Lines of Quality Defense, TOC, COSO and Business Risk with Larry Mager

Let's Combinate - Combining Drugs and Devices

On this episode, I was joined by one of my favorite guests, Larry Mager of Mgmt-Ctrl and PQMCoach.com. Larry walks through:

• Predictive Quality Management and PDCA
• Business Process Capabilities and process stewardship
• 3 Lines of Quality Defense
• COSO Risk Management

Larry is the Principal and Founder at Mgmt-Ctrl, a company that focuses on bringing thoughtful quality management that goes beyond compliance only. He has three decades of experience in the medical device industry, and has held responsible positions within medical device manufacturing companies ranging from start-ups to multisite, highly matrixed organizations. He has held executive management responsibilities in both quality management and operations management roles and is experienced in interrelated quality disciplines, such as quality systems, management control, CAPA, supplier control and management, risk management, quality assurance/control, lean manufacturing, product development engineering, and results-oriented management for continuous improvement. You can reach Larry at [e-mail]