James Bradburn

Americas Pharmaceutical Manufacturing Solution Executive,
IBM Business Consulting Services

"21st Century Pharmaceutical Manufacturing"

Abstract

Product evolution, market dynamics and regulatory transformation are causing significant disruption in the pharmaceutical industry. The case for change is impossible to ignore. Moving from today's static production to tomorrow's scientific manufacturing requires data sharing and process collaboration between development and manufacturing.

Biography

He has over 28 years involvement in pharmaceutical and medical device manufacturing, including plant operations and production management. He has focused for the past 15 years on information technology supporting manufacturing/quality functions and regulatory compliance.

He is a member of the Life Sciences Regulatory Compliance team, which is focused on FDA and EU regulations affecting pharmaceutical and medical device manufacturers, and specializes in information technologies that enhance production and quality operations.

He has also designed, developed, and implemented numerous system applications for drug/device manufacturing operations, including Product Data / Costing, Electronic Document Management, Manufacturing Execution/Electronic Batch Records, Training Management, Corrective Action, Inventory Management, and other plant operational systems.

He has been a frequent speaker on manufacturing systems, 21CFR11 compliance, and computer validation at industry conferences and seminars for the past 12 years.