Event:
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Managing FDA Inspections from Readiness through Follow up
Responses: One and a Half day In-Person Seminar
- Hosted By:
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ComplianceOnline
- Start:
- Thursday - Apr 24, 2014 08:30 AM
- End Time:
- Friday - Apr 25, 2014 01:00 PM
- Location:
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San francisco,
California, United States
- Course Description:
If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:
-Has your company ever been unprepared for an FDA inspection?
-How should one respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
-What the agency can and cannot ask for during an inspection?
Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.
Learning Objectives:
This course on managing FDA inspection will:
-Define the steps necessary to prepare for an FDA inspection
-Discuss details surrounding the management of inspections from announcement to close out meeting
-Offer responses to FAQs regarding typical inspector requests during inspections
-Define the methodology for responding to 483 and warning letters
-Offer templates for response letters
-Discuss common pitfalls to avoid during an inspection
Who will Benefit:
This course will provide valuable assistance and guidance to all regulated companies (pharmaceutical, biopharmaceutical, biologics, medical device etc) that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:
-Internal Auditors
-Regulators
-Legal Departments
-Compliance Officers
-Validation Managers
-QC Managers
-QA Managers
-Facilities and Engineering Department Staff
-Compliance Consultants
-Senior Management
- Website:
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Visit the website for detail info