Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter -- ComplianceOnline Medica (Medical Device)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Jan 25, 2011 End Date/Time: Jan 25, 2011
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Description

This Medical device inspection webinar training will teach you A to Z of inspection starting with how to prepare to what to do during inspection, close-out interview, FDA’s scope, what documents to show and how to respond to the inspection.

Why You Should Attend:

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.


Note: Use these promocode(117660) for 10% discount.

Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
MORE INFO ON THIS VENUE