The FDA’s Office of Compliance is reorganizing to better address the challenges of globalization, regulatory harmonization and controlling a global supply chain. Part of FDA’s changes include increased citation of ICH guidance in Warning Letters and FDA Form 483s. And FDA inspectors are now being trained on ICH, GHTF and PIC/S guidelines when it comes to auditing firms for supplier control. Are you ready for the globalized FDA inspector?

This audio conference presentation provides attendees with a roadmap to successfully integrate regulatory harmonization and risk management into supplier selection, qualification, and management. The presentation highlights current FDA inspector thinking and questions to prepare for, along with a review of the hidden risks that companies inadvertently stumble into when transitioning to global supplier qualification and management. Our speaker also walks attendees, step-by-step, through the best practices necessary to implement a successful program that meets the challenges of 21st century global supply chain and current FDA inspector expectations.

This audio conference covers:

• The most common FDA inspector questions regarding supplier control
• Types of suppliers that need to be controlled under regulatory harmonization rules
• Key elements of a regulatory harmonized supplier qualification and management program
• How to design and implement risk-based supplier oversight controls
• How the FDA has used the harmonized regulatory guidelines in enforcement actions
• The SOPs that make up an effective global supplier management program
• What records will the FDA inspector will request?
• How to qualify and manage suppliers who are virtual companies
• How much effort should be put into supplier contracts and quality agreements?
• At what point should on-site supplier audits be performed - and how often?
• How to document good supplier oversight
• To what level should senior management be involved?

Related event:  How to Respond to FDA 483s and Warning Letters

About the speaker:

John Avellanet is an internationally renowned speaker and authority on lean compliance topics of supplier management. He spent 15 years personally accountable for regulatory compliance and vendor oversight, most recently as a C-level executive in a combination biopharmaceutical and device Fortune 50 subsidiary. Since founding Cerulean Associates LLC in 2006, he’s traveled around the world helping clients and solving problems with practical, innovative solutions to strengthen compliance while lowering costs and reducing risk. In 2010, Mr. Avellanet trained FDA and Health Canada directors on best practices in other industries to qualify and oversee virtual and global suppliers. Mr. Avellanet has been interviewed on multiple radio programs and in media podcasts, and his most recent book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, was featured at BIO 2011.

Who should attend?

• Quality Assurance Directors & Managers
• Vendor Management
• Purchasing Professionals
• Contract Manufacturers
• Research Organizations