Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

A. HAMID MOLLAH, PhD, is the Head of Quality Engineering and Validation at XOMA. He has also held positions at Genentech and Baxter. He is a RAPS Certified Regulatory Affairs Professional and ASQ Certified Quality Engineer. Dr. MIKE LONG, has two decades of experience leading product, process development, and validation efforts on a wide range of pharmaceutical, medical device, and combination products. He is a frequent speaker and writer on topics such as risk management, quality systems, quality by design, and process validation. HAROLD S. BASEMAN, MBA, Principal and Chief Operating Officer, ValSource LLC, has more than thirty years of experience in pharmaceutical operations, validation, and regulatory compliance. He has held positions in executive management and technical operations at several manufacturing and consulting firms.

1 Introduction and Background Hal Baseman and A. Hamid Mollah 2 Risk Management Tools Mark Walker and Tom Busmann 3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration Mike Long 4 Statistical Topics and Analysis In Risk Assessment Mike Long 5 Quality by Design Bruce Davis 6 Process Development and Clinical Manufacturing Karen Ginsbury 7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment Hal Baseman and Mike Bogan 8 Quality Risk Management in Process Lifecycle Validation A. Hamid Mollah and Scott Bozzone 9 Aseptic Processing: One James Agalloco and James Akers 10 Aseptic Processing: Two Edward C. Tidswell 11 Pharmaceutical Product Manufacturing Marlene Raschiatore 12 Quality Risk Management in Biopharmaceutical Manufacturing Ruhi Ahmed and Tom Genova 13 Risk Based Change Control Bill Harclerode, Bob Moser, Jorge Ferreira, and Christophe Noualhac Index