Anatomy of a Medical Device Inspection: From EIR to 483 to Warning Letter - Medical Device Webinar By ComplianceOnline

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.

Areas Covered in the Seminar:

How to prepare for an FDA inspection.
Development and contents of an SOP for FDA inspection.
Personnel training before inspection.
How to behave during an inspection.
Limitations of scope of inspection.
Response to investigation findings.
FDA guidance documents used by their inspectors.

Who Will Benefit:

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

Executive/senior management
Regulatory management
QA management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality system auditors