The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: May 7, 2015 at 9am to May 8, 2015 at 5pm
Location: Four Points By Sheraton French Quarter
Street: 541 Bourbon St New Orleans, LA, 70130 United States
City/Town: New Orleans
Website or Map: https://www.globalcompliancep…
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Feb 24, 2015
FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. The course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents. What the investigator does and what FDA does are not mysteries, they just seem like it.
Casper (Cap) Uldriks through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. As an investigator, he was responsible for countless 483s, scores of Warning Letters, injunctions, individual seizures, mass seizures and was coined by industry as FDA's "Darth Vader." He inspected foods, drugs, methadone clinics and clinical investigators, but specialized in the FDA's medical device program. He served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health.
NetZealous BDA as GlobalCompliancePanel