Webinar · Palm Beach, Florida
FDA's Foreign Inspections Requires Special Management
Health · Medicine · Pharmaceuticals
Key numbers
- Editions on record
- 1first in 2015
About FDA's Foreign Inspections Requires Special Management
Overview:
Foreign manufacturers face special difficulties when FDA conducts an inspection. The logistics of scheduling an inspection involve much more than firms realize and involves interaction with other federal agencies. Although foreign manufacturers and U.S. manufacturers must conform to the same manufacturing requirements, there are language barriers.
There may be misunderstandings during an inspection that create needless problems. A foreign firm's response to an inspection plays a critical role in how FDA evaluates the firm, something many foreign firms failure to appreciate. Some foreign firms truly do not understand the devastating consequences to their U.S. market. Foreign firms need to develop a strategy for how they prepare for an inspection, how to conduct an inspection and how to respond to an inspection. A failure in any of these steps may lead to the firm being placed on an Import Alert, which closes the U.S. market until the firm passes an inspection. That process does not happen quickly. For international commerce, that kind of delay translates into a big hit on the balance sheet.
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2015 | 13–14 Jan 2015 | Webinar Venue Online | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is FDA's Foreign Inspections Requires Special Management?
The next dates haven't been confirmed. The last edition we have on record was 13–14 Jan 2015.
Where is it held?
The last edition we have was at Webinar Venue, Palm Beach, Florida.