Qmed Webinars & Online Courses

  • The Secret to Accelerated Innovation AND Increased Compliance

    In today’s increasingly complex market, some medical device companies fear stricter regulatory standards will compromise their ability to accelerate innovation. Fortunately, that is not true. Solid design control business practices coupled with a modern product design solution can ensure medical device companies — even those with globally disseminated supply chain teams — achieve compliance without sacrificing accelerated innovation. Join Topera’s Quality Assurance Director Ken Perino and Arena Solution’s Validation Program Manager Yelena Bolton to learn how medical device companies are balancing business and compliance with their design control process.

    Wed, Jan 21, 2015 - 02:00 pm


  • Packaging Considerations for Contract Manufacturing

    What considerations should a medical device OEM keep in mind when designing a package ready for sterilization and sale to the final customer? This webinar addresses many of the items that a device designer should keep in mind when getting a product ready for presentation to a contract manufacturer. Design for robust device packaging can save hundreds of thousands of dollars in reworked projects and timelines and can eliminate costly field corrective actions.

    Mon, Dec 15, 2014 - 08:00 am - Tue, Dec 15, 2015 - 08:00 am


  • Biocompatibility: Rethinking the New Big Three (Cytotoxicity, Sensitization & Irritation Testing)

    This webinar will examine how the “Big Three” biocompatibility tests (cytotoxicity, sensitization, and irritation) are advancing and what those advancements mean for medical device manufacturers. In addition to the Big Three, course registrants will learn about the in vitro sensitization/irritation testing model, and what is being done to ensure regulators accept in vitro alternatives. Additionally, registrants will receive insight into the value of in vitro testing as a means of reducing testing costs, and accelerating time to market.

    Thu, Nov 20, 2014 - 02:00 pm


  • The Power of Chemical Characterization to Assess Changes in Your Medical Device

    This webinar will discuss chemical characterization and how these test methods can help evaluate the impact of a change to the overall biocompatibility of the device. Medical device manufacturers will walk away with a better understanding of chemical characterization and how to evaluate changes.

    Wed, Aug 13, 2014 - 08:00 am


  • Managing Human Factors in Reprocessing of Reusable Devices - Validation Considerations

    The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge and recommendations about how to manage the human factors in processing of reusable medical devices.

    Wed, May 21, 2014 - 08:00 am


  • Optimal Catheter Design: Making the Smart Choices When Selecting Materials and Manufacturing Processes

    Today’s sophisticated catheters have become modern marvels of advanced design and polymer technology. This information-filled presentation will help you make the right choices of materials and production processes to achieve cost and performance objectives of a catheter-based project while avoiding the pitfall of over engineering. Topics include cost/benefit trade-offs offered by different manufacturing technologies and the integration of advanced polymers’ characteristics into the design of next-gen catheters.

    Thu, Sep 26, 2013 - 02:00 pm - Mon, Sep 26, 2016 - 02:00 pm

    60 minutes

  • Microbial Identification: When to Do It and How It’s Done

    Understanding the nature of the microorganisms in manufacturing environments and on or in products is a vital step in medical device and pharmaceutical processing. In this webinar we will discuss the compendial requirements and recommendations regarding:The importance of microbial identification in an environmental monitoring program.How microbial identification is an important tool with gamma sterilized medical device validations in understanding a product bioburden baseline, in defining product families and in determining the frequency of dose audits.How microbial identification can be critical in investigations of environmental excursions, bioburden spikes, sterility failures, Biological indicator (BI) testing and Microbial Limits screening.Information will be included on microbial identification testing at Nelson Labs, from the benefit of sub-culturing organisms to the importance of a Gram stain as part of a polyphasic approach to identification.

    Thu, Aug 29, 2013 - 11:00 am

    45 minutes

  • 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