Coping with a Difficult Compliance Officer when Responding to a 483, Warning Letter, Import Alert or Recall
August 9, 2013 - Palo Alto CA US
This webinar on handling FDA inspectors will discuss practical tips to cope with a difficult FDA compliance officer or inspector. You will learn how to wiggle out of complicated situations, make legal arguments and challenges to the FDA agent and use meeting requests and other tools to ease tensions. Why Should You Attend: How do you deal with a difficult compliance officer or recall coordinator? How do you know when to push back, to cry foul, or ask for the district compliance director to be involved? When should you make legal arguments and challenges? Inspections by the FDA are perhaps the most intimidating and stressful of all events at a regulated facility. That stress can be amplified exponentially when dealing with a difficult compliance officer or recall coordinator. Many industry 483 observations shouldn't have been received at all. Most Warning Letters could have been easily prevented. Responses can be compounded and the time to a close out letter drawn out. During this session, you will learn how to work with a difficult compliance officer and resolve tricky compliance situations before any damage can be done. We will also explore common scenarios that can cause compliance difficulties for you and what you should do to avoid them. At the end of the webinar, the instructor will answer any and all questions specific to your industry or facility. Attendance to this training will be limited to ensure every participant gets time for interacting with the speaker. The instructor is an attorney and a veteran with extensive experience in working with both the FDA and USDA on compliance, recalls, and import matters. Areas Covered in the Webinar: Outline of FDA enforcement and compliance scheme. FDA inspection process. Lead up to a warning letter - warning signs. Warning letter issuance. Company response to FDA warning letters. When to make legal arguments and challenges How to cry foul to the district compliance officer Meeting requests and other tools to ease tensions Who will Benefit: Food & beverage industry executives Dietary Supplement manufacturers/distributors Medical Device manufacturers/distributors In-House Legal Counsel Regulatory Affairs Government Affairs Distributors and manufacturers Customs brokers FDA/Food & Drug Attorneys Instructor Profile: Marc, represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device and drug industries. With a focus on international trade, he advises clients on the regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. Marc is a frequent national speaker on FDA compliance issues and is considered a leading voice in understanding the Food Safety Modernization Act, which has fundamentally changed food law in the U.S., with interviews and contributions in the Washington Post and Huffington Post. For the food industry, Marc’s practice includes working with both the FDA and USDA on compliance, recalls, and import matters. His clients rely on his ability to equally balance market opportunity with risk exposure. The result is a philosophy that utilizes a client’s strengths in adapting to regulatory issues and market limitations. Marc’s strategy is to develop smart corporate governance along with regulatory compliance. In 2011, Marc founded Contract In-House Counsel and Consultants, LLC to offer a broad range of services to the medical device and food industry. He currently serves clients across the US, EU, China and Middle East. Marc received a masters in international commercial policy from Valparaiso University and earned his JD from Lewis and Clark College. He is a member of the Washington Bar Association and the Regulatory Affairs Professionals Society.