is being presented by John Avellanet, Managing Director & Principal, with Cerulean Associates LLC and airs on Tuesday, January 31st, 2012. For more details or to register, please visit our site at www.fxconferences.com
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.
