Today: October 23, 2016, 3:16 am
Education & Career

"The FDA Inspection: Preparation, Performance, and Follow-up" 2014-08-08 13:56:12
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.

Areas Covered in the Session

How to prepare for an FDA inspection
Development and contents of an SOP for FDA inspection
Personel 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: (Titles)

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
Quality system auditors

Webinar Includes:

Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance

Press Information
10777 Westheimer Suite 1100



Published by
jay sylvester

# 301 Words
Related Articles
More From Education & Career
LiveteachingTV Announces Their Campaign Launch on Indiegogo
New York, NY October 5, 2016—New startup LiveteachingTV announced that they are raising funds via a rewards / equity crowdfunding [..]
New Traders - Invites You to [..]
Ready to learn what it takes to become a day trader?  Now is your chance as a new date has [..]
Empowering Students with Study and Soft Skills [..]
-- In support of Childhood Cancer Awareness Month, iStudyforSuccess, an online educational tool that helps students improve their [..]
ASSK Academy Invites Admissions for It’s Newly [..]
Financial Modeling course is aimed to provide professionals skills to analyze real life financial situations. The training institute [..]
Select Teachers launches State of the ESL [..]
Shanghai-based Select Teachers today launched its State of the ESL Industry Survey for teachers who teach English as a Second [..]

Disclaimer: If you have any questions regarding information in this press release please contact the company added in the press release. Please do not contact pr-inside. We will not be able to assist you. PR-inside disclaims the content included in this release.