Managing Your FDA Inspection: Before, During and After (ntz)<br />At<br />Courtyard by Marriott Seattle Sea-Tac Area<br />For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV<br /><br /><br />DESCRIPTION<br />===========<br />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. <br />During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. <br />As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions.<br /> If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. <br />FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. <br />he 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. <br />What the investigator does and what FDA does are not mysteries, they just seem like it.<br /><br />Why you should attend:<br />"Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol. <br /><br /><br /><br />For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV<br /><br />Areas Covered in the Session<br />============================<br />FDA legal authority<br />Types of inspections<br />FDA investigator training<br />FDA's written procedures, policy and operations guide<br />Industry inspection protocol<br />What to do and not do during an inspection<br />Form FDA 483 response<br />Warning Letter response<br />Enforcement<br /><br />Who Will Benefit:<br />=================<br />Regulatory Affairs<br />Quality Assurance<br />Manufacturing<br /><br /><br />Casper Uldriks<br />ex-FDA Expert and former Associate Center Director of CDRH<br /><br />Please contact the event manager Marilyn below for the following:<br />- Discounts for registering 5 or more participants.<br />- If your company requires a price quotation.<br />Event Manager Contact: marilyn.b.turner(at)nyeventslist.com<br />You can also contact us if you require a visa invitation letter, after ticket purchase.<br />We can also provide a certificate of completion for this event if required.<br />----------------------------------<br /><br />For more information: https://www.eventbrite.com/e/managing-your-fda-inspection-before-during-and-after-ntz-tickets-38757786583?aff=RMV<br /><br />Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675<br />Twitter: https://twitter.com/nyeventslist<br />Facebook: https://www.facebook.com/NewYorkEventsList<br />New York Events List: http://nyeventslist.com/
