Food Industry Update – Responding to an FDA Form 483

is being presented by Lisa Capote, Partner, with Arrastia & Capote LLP and airs on Thursday, February 23rd, 2012. For more details or to register, please visit our site at www.fxconferences.com

On January 4, 2011 President Obama signed into law the FDA Food Safety Modernization Act (FSMA). As part of the new regulation, FDA will provide oversight, ensure compliance with requirements and respond effectively when problems emerge. The FSMA mandates inspection frequency based on risk for food facilities, and requires the frequency of inspections to increase immediately. The law directs FDA to inspect at least 600 foreign food facilities within one year of enactment, and double those inspections every year for the next five years. Odds are, that will in turn lead to the issuance of a great deal of additional Form 483s to companies that have never before seen one, let alone had to respond to one.

This audio conference presentation provides detail on the FDA's plans for increased facility inspections, and looks at the most likely areas of scrutiny for inspectors in the coming months. Our speaker shares insight on the steps you can take to ensure a successful inspection, and, in the event your company receives a Form 483, how best to respond so as to avoid a re-inspection.

Using FDA’s Regulatory Harmonization to Better Manage a Global Supply Chain

is being presented by John Avellanet, President, of Cerulean Associates LLC and airs on Wednesday, July 27th, 2011. For more details or to register, please visit our site at www.fxconferences.com

The FDA’s Office of Compliance is reorganizing this year 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. Presented by international supplier management and lean compliance expert John Avellanet, author of the acclaimed book, "Get to Market Now! Turn FDA Compliance into a Competitive Edge", the audio conference 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. Mr. Avellanet 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.

How to Respond to FDA 483s and Warning Letters

Dealing with the FDA is never easy, but two of the most disconcerting times for medical device companies are when an FDA investigator issues a List of Observations (the FDA483) at the conclusion of an inspection, and when you receive a letter from the FDA by certified mail that has "Warning Letter" written at the top.

Now what do you do? The 483 never says you must reply either verbally or in writing, but the warning letter states that you must respond to FDA concerns in writing within 15 days. How do you respond to the 483 and/or the warning letter? Does it make a difference in how you make your response? Who reads your response and what effect does a good response have on the FDA's next regulatory step? Join us as device consultant and former FDA supervisor Alan Schwartz provides the answers.

How to Respond to FDA 483s and Warning Letters is presented by Alan Schwartz, Executive Vice President, of mdi Consultants, Inc. For more information on this audio conference, please visit our site www.fxconferences.com