The increasing use of outsourcing and offshoring by FDA-regulated companies for strategic and cost purposes has greatly improved business outcomes and efficiencies. Unfortunately, despite the clear benefits, there are many significant challenges to structuring and managing these relationships to minimize the risk of FDA enforcement, particularly in the new, more aggressive FDA enforcement climate.

In this audio conference, our speaker provides some business context regarding the use of offshoring and outsourcing, and discusses issues and considerations in structuring relationships, as well as considerations in planning for FDA review and inspection of oversight programs.

This audio conference covers:

• How to select a contractor
• Managing contract relationships
• Elements of the quality system interface
• Current FDA requirements & expectations
• How the FDA might change its approach
• What your company should be doing over the next 18 months

About the speaker:

John C. (Jack) Garvey, founder of Compliance Architects, is an accomplished, broad-based FDA regulatory and compliance executive with over 25 years of experience developing and leading quality, regulatory and compliance initiatives at top FDA-regulated companies. In recent years, Jack has focused on compliance and quality strategy development and deployment for leading life-science companies. In addition to experience gained through roles of increasing responsibility and accomplishment at Accenture, Johnson & Johnson, BASF, and C. R. Bard, Jack’s dual background in law and engineering provides unparalleled ability to resolve today’s complex regulatory, quality and compliance issues.

Jack’s extensive GMP, QSR, GLP and regulatory compliance experience includes quality systems development and re-structuring, inspection preparation, clinical compliance, and FDA-483 and Warning Letter response planning. Operational experience includes directing international, project-based teams in matrix environments on supply-chain and compliance harmonization activities and hands-on experience applying operational excellence methodologies to regulated operations.

Who should attend?

• Quality Assurance/Quality Control Managers
• Regulatory Affairs Directors/Managers
• Purchasing/Procurement Managers
• Directors of Operations
• Compliance Managers