Webinar on FDA Foreign Inspections

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FDA Foreign Inspections
Product Id
FDB1126
Food, Drugs Biologics
Category
Scheduled On
Wednesday, July 23, 2014 at 1300 Hrs
Duration
60 Minutes
Speaker
Casper E. Uldriks
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• Webinar Description

FDAs 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
firms 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. Firms 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. FDAs 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.

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Area Covered in Session

• How FDA prioritizes inspection assignments
• How FDA prepares for inspections
• A firms 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

Speaker Profile
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. 
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