Managing FDA Inspections from Readiness through Follow Up Responses | October 19, 2015 8:30 AM - October 20, 2015 1:00 PM | Automation.com

Managing FDA Inspections from Readiness through Follow Up Responses

Event Summary

DATE:
October 19, 2015 - October 20, 2015
LOCATION:
Orlando, FL 32821
COUNTRY:
USA
START DATE/TIME:
October 19, 2015 8:30 AM
END DATE/TIME:
October 20, 2015 1:00 PM
EVENT TYPE:
Training
HOST:
ComplianceOnline
PHONE:
888-717-2436
EMAIL:
[email protected]
WEBSITE:
Click here to Visit

Description

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


For Registration - http://www.complianceonline.com/managing-fda-inspections-from-readiness-through-follow-up-responses-seminar-training-80156SEM-prdsm?channel=automation


Note: Use coupon code 232082 and get 10% off on registration.

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