The FDA is cracking down on corporate executives, using the Park Doctrine and the FDAAA to impose civil penalties, jail time and industry bans.

This audio conference presentation focuses on the things your management team needs to be doing on a regular, consistent basis to 'ensure the suitability and effectiveness' of your company's quality system. Our speaker, who is president of an independent review organization (IRO) for a current consent decree, provides insight on what FDA investigators and district officers expect to see from your management team. Attendees discover the crucial difference in the eyes of FDA between responsibility and accountability, and how it affects delegating work to staff and suppliers. The presentation also discusses how to ensure your management team is effectively and appropriately engaged, and what proof you need to provide the agency investigators.

This audio conference covers:

• FDA's rationale in the Park Doctrine and in US v. Friedman for increasing stringency
• The FDA investigator's strategy to uncover poor management involvement with compliance and quality
• Specific FDA investigator questions designed to assess management oversight
• The 7 crucial responsibilities of management that must regularly generate proof
• How to incorporate these 7 responsibilities into the quality system
• Specific examples of what these 7 responsibilities look like in the real world

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
• Regulatory Affairs Directors & Managers
• Compliance Directors & Managers