FDA Recalls - Before You Start, and After You Finish
Former Associate Center Director of FDA's CDRH
Former Associate Center Director of FDA's CDRH
FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that, "You don't get it."
Your compliance competency becomes a regulatory issue for the FDA if your recall is deemed ineffective. The seminar will cover critical performance targets for conducting an effective recall. You will learn how missteps in the recall process become an expensive problem in terms of money and a sloppy corporate image.
You will take away practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action, and in some cases a legal action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the negative impact of a recall with the use of proper planning.
Companies and departments:
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.
Benefits of becoming a Sponsor/Exhibitor/Media Partner:
For more details and other sponsorship options at this event, please contact Event Manager: firstname.lastname@example.org or call: +1-650-238-9656Media Partner:
Explore a quaint historic town just over the Potomac River from Washington, DC. The lively waterfront area has plenty of things to do. Visit colonial houses, public parks, churches, museums, a marina, unique shops, and restaurants.
The Washington DC region is lucky to have this wonderful historic park that offers a quick relief from hectic city life. Take the whole family for a walk and learn about the historic C & O Canal, explore the region's bike trails or spend a few hours kayaking and enjoying the breathtaking scenery.
Take a picnic and enjoy spectacular views of the Potomac River at this 800 acre park, located just 14 miles from Washington DC. Great Falls offers a variety of activities including hiking, kayaking, rock climbing, bicycling, and horseback riding.
Georgetown is the capital’s historic waterfront that today is bustling with activity. The area is a shopper’s paradise and the streets are lined with restaurants of every nationality. Take a tour of historic sites, do some shopping and enjoy a meal at a local restaurant.
Explore the U.S. Capitol Building, the White House and the U.S. Supreme Court and you will gain a fuller understanding of the division of power within our democratic government. Plan ahead and note that some tours must be scheduled in advance through your Congressional Representative.
Live theatrical productions at the John F. Kennedy Center for Performing Arts are entertainment at its finest. Purchase tickets in advance for performances ranging from musicals to concerts by the National Symphony or see a free show at the Millennium Stage.