Webinar on FDA Foreign Inspections

1. ContactUs:416-915-4458 WeEmpower,YouComply! FDA Foreign Inspections ProductId FDB1126 Food, Drugs & Biologics Category ScheduledOn Wednesday, July 23, 2014 at 13:00 Hrs Duration 60 Minutes Speaker Casper E. Uldriks Toregisterforthiswebinarpleasevisithttps://compliancetrainings.com/siteengine/Login.aspx • WebinarDescription: FDA’s applies U.S. regulatory requirements to foreign manufacturers during an inspection under strict time constraints. A successful inspection requires thorough preparation and practical logistics that can make or break the outcome. If you are not prepared, a failed inspection means that the FDA is likely to refuse the entry of the firm’s products. The webinar covers what FDA does and what you should do to prepare for an inspection, how you should manage the inspection as it takes place and what to do if you have problems. Firm’s that end up with inspectional observations or a Warning Letter have a lot of work to do in a very short time frame. The webinar will provide a “quick start” guide for what you should do to survive a regulatory disaster. FDA’s import program has become complex and sophisticated. A successful import business requires a working knowledge of critical import requirements and what to do when a requirement is not met. You will learn what the FDA regulatory hurdles are, how they work and how you can work with them in an efficient and effective way. You will also learn how the U.S. Customs and Border Patrol and FDA work in tandem.

2. Area Covered in Session • How FDA prioritizes inspection assignments • How FDA prepares for inspections • A firm’s logistical preparation of an inspection • How to inter-act with the FDA on-site • How to respond to problems “observed” by FDA or a Warning Letter • How to manage import refusals and detentions Who will benefit • Foreign Manufacturers and Holding Companies • Initial Importers in the U.S. • Foreign Exporters • U.S. Initial Importers • U.S. Customs Import Brokers • International Regulatory Affairs Managers • Financial Planning Managers • Business Planning Executives • Business Acquisition Executives • Owners of New or Developing Import/Export Firms • International Trade Managers • Sales and Marketing Managers SpeakerProfile: Mr. Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs.  To know more visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1126