2014 - FDA's Inspection of Foreign Device Manufacturers

Overview:
FDA inspects foreign manufacturers to assess their compliance with the same manufacturing requirements that apply to U.S. firms. How you and the FDA conduct the inspection can make a huge difference on the outcome. The inspection can have a significant if not disastrous impact on a foreign firm's current and future business in the U.S.
Managing a foreign inspection is critical, but often foreign firms do not understand what the FDA inspection means and how to interact with the FDA investigator. Foreign firms face critical time frames during and after the inspection that may find them unprepared, much to their detriment. Prior planning and established procedures are necessary. This is not the time to face a steep learning curve. Delays or inadequate responses to FDA may result in a firm being placed on Import Alert, which blocks the firm's products from entering U.S. commerce.
Why should you attend:
Foreign manufacturers face new and stringent FDA regulatory controls. FDA inspections and regulatory requirements leave foreign manufacturers easy targets for inspectional observations (FDA-Form 483), Warning Letters, import detention and import refusals. Foreign manufactures face the same rigorous manufacturing requirements as U.S. manufactures. What is different though is that FDA can take relatively swift regulatory action with its automatic detention of imported products due to a firm's failure to survive a Good Manufacturing Practice inspection.
Failing to manage or respond effectively to an inspection, a foreign establishment can face a failing future with its business in the U.S. How can you effectively prepare for an inspection? How can you manage an inspection to avoid misunderstandings? How can you cut your immediate and future business losses if you have had a tough inspection? The webinar will point you in a practical and productive direction.
Areas Covered in the Session:
Regulatory basis for foreign inspections
Inspection process and strategy
Inspectional observations (FDA-Form 483)
FDA's post-inspection procedure
Import detention and refusals
Re-inspection and logistics
Who Will Benefit:
Initial importers in the U.S.
Sole source importers
Foreign manufacturers
International regulatory affairs managers
Import brokers
Financial planning managers
FDA import consultants
Carriage and product distribution managers
Quick Contact:
GlobalCompliancePanel
USA Phone:800-447-9407
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Link - http://bit.ly/1rDmmVQ