Regulatory Considerations & Revalidation Tests for Managing Change in Packaging Materials or Critical Supplies
When a critical supply for your product or process changes, there are several regulatory items that you should consider. Regulatory bodies, such as FDA, expect that you will be able to show your due diligence in assessing the risk and impact to your product/process. This webinar will provide guidance to navigate through a supplier change for packaging materials by providing a comprehensive approach to regulatory considerations for managing the change. Also included in this webinar is a review of packaging test methods for validation of sterile barrier materials and the testing required as outline in ISO 11607.
Sun, Jan 1, 2012 - 01:04 pm
This topic is designed to provide information for the beginner and the intermediate level person seeking further details into the Radiation sterilization process. The training starts with the fundamentals of testing involved in radiation validations including the necessary key terms and definitions and an overview of bioburden and sterility testing. The training then describes the common validation approaches The different types of methods for doing radiation sterilization including VD Max, Method 1 and Method 2 are discussed in detail. Lastly the topic covers several other key concepts involved with radiation sterilization.
Mon, Dec 5, 2011 (All day) - Thu, Dec 31, 2015 (All day)
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge to make decisions regarding which tests should be used to validate their sterile barrier system. By focusing on specific tests as outline in ISO11607, each individual will have the opportunity to view actual test methods, determine appropriate test samples and identify pros and cons to each method. Some of the methods viewed will consist of Bubble Emission (ASTM F2096), Microbial Ranking (ASTM F1608), Burst Testing (ASTM F1140), Seal Strength Testing (ASTM F88), and Dye Migration (ASTM F1929).
Wed, Jul 20, 2011 - 01:47 pm
There’s a myriad of tests medical device manufacturers need to be prepared to conduct on their creations in order to pass regulation requirements before they are released to the marketplace. None more important than the Cytotoxicity, Sensitization, and Irritation tests—the Big Three as we call them. They are the Big Three because they must be conducted on every device before they can be submitted to the Federal Drug Administration (FDA). There is no way you can get around doing the three tests. Other tests may or may not need to be conducted.
Fri, Apr 29, 2011 - 02:20 pm
This webinar is designed to acquaint those in the medical device community with the appropriate ways to develop, optimize, and validate an ethylene oxide sterilization process. The properties and hazards associated with ethylene oxide and the process required to successfully validate a medical device will also be discussed. The validation methods used are outlined in ANSI/AAMI/ISO 11135-1:2007. Some of the related testing includes comparative resistance, bioburden resistance, bioburden enumeration, sterility testing, sterilant gas residues, and temperature/humidity distribution studies. In addition, the batch release method will be outlined. This process allows the manufacturer to sterilize a single lot of product for use in clinical trials or animal studies where large numbers of samples are not available. This provides a rapid and cost effective way to provide sterile product without undergoing the full validation process.
Fri, Dec 3, 2010 - 09:00 am
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