FDA Audits – Preparation, Performance During The Inspection, Handling The Results

MessageThis Webinar is over
Date Oct 8, 2018
Time 01:00 PM EST 90 Minutes Live Webinar
Cost $213.00
Online
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Not to be prepared for an FDA inspection is like playing roulette – the odds are always with the house. Simply stated you just cannot go through every day in a regulated environment without thinking about being compliant. Being compliant means doing the right things right. Doing the right things right consists of building a solid sustainable culture of compliance within your organization. A critical part of that process is to be inspection ready.
Not being inspection ready results in chaos from the moment the inspectors knock on the door - no matter how well structured, well-documented, and GMP compliant your processes. So what exactly are we talking about? In addition to the basics and getting those right, you must implement a robust process of conducting mock audits and training all personnel in inspection best practices to include behavioral training.
Now what’s at stake? Why expend the time and resources to be inspection ready? The reason is that the FDA is increasing its focus on regulatory oversight. There is more of a potential than ever before of an unscheduled inspection occurring not to mention the normal scheduled inspections. The results of a compliance breach depending upon its severity can be huge – from harm to our patients to significant fines and legal action against the organization.
Every person in the organization has a role to play in compliance excellence and inspection readiness.
The webinar is designed to apply to all levels of knowledge and ability – Basic, Intermediate, Advanced.
Highlights Of the Session:
  • The primary reasons why the FDA conducts inspections
  • The FDA’s risk-based oversight process and their increased collaboration with foreign regulatory counterparts
  • What is the usual timing of FDA Inspections
  • How do you become inspection ready – what steps should you take
  • Building a culture of inspection and compliance readiness into your organization
  • What occurs during an FDA inspection – what is the process
  • The outcomes of an FDA Inspection and how they must be handled
  • Inspection best practice
Who can attend:
This is an all-inclusive webinar benefiting all individuals within the organization but particularly those in positions of management and supervision. Vice Presidents, Directors, Associate Directors, Managers and Supervisors in ALLfunctions will benefit from this organization. Significantly, compliance and regulatory who spearhead the inspections and are responsible for compliance readiness, as well as training that should be building on-going training around this subject should also be included.

 


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