Qmed Webinars & Online Courses

  • How the New FDA Guidance on ISO 10993 Could Possibly Affect You

    In April of 2013 the FDA released a draft guidance on using ISO 10993 for biocompatibility. This draft is intended to replace the #G95-1 document on the current thinking and application of biocompatibility testing for medical devices. In the webinar we will cover three areas of the new document:1. Summary of ideas that are currently practices by the FDA but this is the first instance that they are put in writing 2. Concepts that can be used for justifying testing plans, and 3. New ideas that are not current thinking with the FDA that could change how you are testing.

    Wed, Aug 21, 2013 - 01:00 pm

    60 minutes

  • Masks, Gowns and Drapes – Testing the Barrier Performance of your Product

    This topic will cover the relevant standards and test methods for face masks, gowns and drapes testing. The webinar will include a summary of what tests need to be performed, how these tests are performed, sample sizes, and estimated turn-around times. The goal will be to provide a starting point that will allow you to put together a testing plan that is right for you, your product, your budget and your timeline.

    Fri, Dec 21, 2012 - 08:00 am


  • Ethylene Oxide Clinical Batch Release

    How do you sterilize product when you only have enough product produced to make up one sterilization load? How do you demonstrate a sterility assurance level (SAL) of 10-6 when you do not have the time or sample quantity required for a full EO validation? The batch release method is a rapid and cost effective approach to sterilizing single or small batches of product needed for clinical or animal trials with minimal sample requirements. The presentation on batch release testing gives a general outline on the background and requirements on performing an appropriate sterilization validation for these small or infrequently produced lots. The overkill concept, properties of ethylene oxide, and testing requirements will be discussed. The webinar will demonstrate how the sterility assurance level can be achieved and outline all of the necessary testing required to be able to safely release product. The batch release method can be performed in small laboratory vessels as well as at contract sterilization facilities and provides the much needed flexibility to get product to trials or to market without the time and expense of waiting for the completion of a full sterilization validation.

    Tue, Nov 20, 2012 - 03:44 pm

    Available on Demand

  • Particulate Matter Testing of Cardiovascular Devices

    This webinar is specifically directed to cardiovascular medical device manufacturers that will be conducting particulate matter testing on their product. It’s also applicable to anyone that has questions regarding what steps are necessary to develop a testing scheme, what products should be tested for particulate matter and common pitfalls that manufacturers may encounter when submitting data to regulatory for approval.

    Thu, Jul 19, 2012 - 08:00 am


  • Cleaning Validations for Newly Manufactured Medical Devices and Single Use Implants

    Most medical device manufacturers know the importance of sending their product through rigorous cleaning and testing before they release to market. Standard sterility and biocompatibility tests are already an essential part of many manufacturers' protocols. What may not be as commonly understood, however, are the different ways a product can be contaminated during the manufacturing and production, cleaning processes, and packaging of medical devices. To avoid detrimental contamination, manufacturers should test their devices to examine the surface residues remaining on the device after these processes. This presentation on cleaning validations for newly manufactured medical devices and single use implants is a useful guide to help develop a successful test plan to provide cleanliness data. In addition, this presentation gives guidance on industry trends to justify residue limits.Available On Demand

    Thu, Apr 5, 2012 - 09:00 am

    60 Minutes

  • Cleaning Validations of Reusable Medical Devices

    This on-demand webinar is designed to provide information for the beginner and the intermediate level person seeking further details into performing cleaning validations of reusable medical devices. The webinar covers the fundamentals of the cleaning process and goes into more depth about how to contaminate and perform the dwell time of the devices, what methods are used to clean the devices, what residuals are appropriate to test for specific device types, evaluating the recommended cleaning procedure for a reusable device according to AAMI TIR12:2010 and AAMI TIR30:2003, and the acceptance criteria for each residual tested. This information is needed to assure that once the device has been used, it can be properly cleaned. It is the responsibility of the manufacturer to apply this data, along with their own functionality and sterilization data, to the label claims. Lastly the topic covers several of the standards along with case studies and examples.

    Wed, Jan 4, 2012 - 11:32 am

    60 Minutes

  • 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


  • Radiation Sterilization Validations

    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)

    60 Minutes

  • Packaging Test Methods for Validation of Sterile Barrier Materials

    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

    60 Minutes

  • The Big Three: Cytotoxicity, Sensitization & Irritation

    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

    60 Minutes

  • Ethylene Oxide Sterilization

    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

    60 Minutes