A two presentation series focused on addressing the FDA inspection process and what the healthcare product manufacturer should do to prepare for it and address its findings. Part one will address the FDA process of risk-based inspection, types of inspections, and the system based inspection. The second part will address how to prepare for an inspection, how to address and respond to FDA findings, and finally how to avoid further regulatory action.
Webinar Part I: Tuesday March 2, 2010 Noon-1:30 EST
If you manufacture, process, package or hold drug products you will be inspected by the FDA. There are many types of inspections and as a manufacturer you should be familiar with them and well prepared for them. The FDA has defined risk criteria based on which they would decide on the timing and frequency of inspecting a drug establishment. The so-called risk based inspection is designed to optimize resource utilization for regulators. In this presentation we will review the overall criteria the FDA uses to decide on the location, timing and frequency of inspections. We will also review the systems that will be inspected and look at many recent FDA 483 observations to identify what happens during the inspection and what the FDA focuses on.
The presentation will begin by briefly reviewing the various types of GMP inspections and who from the agency will be present. We will then review the criteria the FDA uses to define their inspection target, the frequency of inspection and the timing of such inspections. The presentation will then focus on the “System Based Inspections” normally conducted by the FDA. In order to understand the system based inspections we will first define what the FDA will look for in each system, review many examples of FDA 483 observations, relate them to the various systems and finally we will emphasize the issues of most concern to the regulators.
This review will set the stage for the second presentation which will focus on preparing for FDA inspections.
Fee: $365 for one (1) person: Webinar Part I ONLY
REGISTER FOR ECCWEB 164
$650 for one (1) person: Webinar Part I AND Part II
REGISTER FOR ECCWEB 166
Discounts are available for multiple participants.
Webinar Part II Wednesday March 3, 2010 Noon-1:30 pm EST
It is incumbent on the healthcare product manufacturer to always be in compliance with GMP requirements and be prepared for regulatory inspections. Armed with the information gleaned from the first presentation we would define several steps to be taken by the manufacturer to prepare for FDA inspections. Additionally we will review in broad terms how to insure that you are in compliance and ready for such inspections at all times.
Not only do you need to anticipate what the FDA will be looking for, but you also need to utilize the resources available to you to ensure that you are in full compliance with the law. This will lead us into a discussion of risk based compliance. Armed with the fundamental principle of protecting the public and minimizing danger to the patients, we will discuss how to apply risk assessment to improve your compliance quotient. Next we will define what you should do and how you should act during the inspection in order to assist the regulator with the inspection and minimize any future deleterious effect. We will also review what you should do once the inspection is over in order to address the regulator’s concern and avoid further regulatory actions such as warning letters, consent decrees, product seizure, closure of operation, and or criminal charges.
By attending these two sessions you will learn
- Why would the FDA inspect (Risk Based Inspection)?
- Who would be the inspector?
- Which systems will the FDA inspect?
- What the FDA looks for?
- How to prepare for FDA inspections?
- What is risk based compliance and how to apply it to your situation?
- What you could do to avoid further regulatory actions?
At the end of each segment we will allow some time for Q&A.
Fee: $365 for one (1) person: Webinar Part II ONLY
REGISTER FOR ECCWEB 165
$650 for one (1) person: Webinar Part I AND Part II
REGISTER FOR ECCWEB 166
Discounts are available for multiple participants.
