OverviewFDA investigations can lead to observations requiring remediation, disruption of your business, loss of revenue and enforcement actions up to and including having your plant shutdown. Come learn from someone who's "been there and done that" having gone through an intense FDA investigation with a global manufacturer of durable medical equipment that resulted in the imposition of a Consent Decree and plant shutdown. Take-away will include practical tips on how to interact with the FDA and create sustainable corrective actions.Why Should You AttendHow would you respond to an FDA investigation? It could be a FDA 483 letter, a warning letter, or a Consent Decree, all of which will impact revenue loss & how you carry on your business while under investigation. Drew Barnholtz has "been there, done that" when it comes to the FDA investigation and Consent Decree process. Learn first-hand of his experience and how his company survived the ordeal.Areas Covered in this WebinarWhat a company should do if the FDA shows up unannouncedHow a company should respond to 483 observations or a warning letterThe affect an FDA investigation can have on a companyThe basic concepts that should be employed by everyone regulated by the FDAHow a company can prepare for situations like the thisLesson learnedLearning ObjectivesLearn how a company can balance the need to prepare for a potential FDA investigation or enforcement action and still run a profitable business.Who Will BenefitCEOsCFOsQuality Affairs PersonnelRegulatory Affairs PersonnelGeneral Counsel/Legal ProfessionalsManufacturing ProfessionalsEngineering ProfessionalsDistribution ProfessionalsSupply Chain ProfessionalsLevelBeginner