New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
Product family grouping is discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013 entitled ‘Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose’. This document is designed to provide general requirements and guidance for establishing a product family for radiation sterilization. This webinar will discuss the concepts found in this document and provide examples of how the guidance might be applied.
Tues, April 26, 2018 (all day)
Duration: 45 minutes
Sponsored by: Nelson Labs
OEMs: Discover The Hidden Costs and Risk In Your Complex Supplier Network
Top medical device OEMs are evolving to optimize their global footprint to stay competitive within the industry, and outsourcing partners must evolve, as well, to adapt to new market demands. In this webinar, you will learn how to develop a stronger partnership with your suppliers by navigating the complexities of OEM supplier networks. VP Engineering, VP R&D, VP Operations, and Sourcing Directors will benefit from watching this webinar.
Tues, April 10, 2018 (all day)
Duration: 25 minutes
Sponsored by: Flexan LLC
Improve Your Design Cycle to Get to Market Faster
Manufacturing processes are critical to part outcome and getting to market faster. It is important to consider key factors that will assist in improving upon your overall efficiency and production timing.
Tues, March 13, 2018 (all day)
Duration: 30 minutes
Sponsored by: Xcentric
In March of 2017, the new ISO 18562 standard series was released. This standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway. This standard greatly increases the scrutiny for gas path devices and their required tests. This presentation will cover the required biological endpoints and the unique test methods to test these devices.
Tues, February 20, 2018 (all day)
Duration: 45 minutes
Sponsored by: Nelson Labs
Automating Policy Management: Document Control, Training and Exception Handling
A dynamic policy management system is critical to an organization’s GRC initiatives. Increased litigation, compliance requirements and a diverse workforce require a well-constructed policy management system to mitigate risk and improve user compliance. Learn how automating and integrating policy management creates a controlled process to design, communicate and track corporate policy and procedure. The presenter will discuss policy challenges and solutions, including development, review and release, attestation and training, revision management and exception handling.
Tues, January 23, 2018 (All day)
Duration: 28 Minutes
Sponsored by: AsssurX
Packaging: Design for Sterilization
Medical device packaging plays a critical role in the efficacy and safety of the device being packaged. Each device will have its own unique requirements for sterilization and the packaging design must support this role. Each sterilization method, EO, steam, gamma and so on presents unique challenges to the packaging design engineer. Armed with a few resources, knowledge of the sterilization method, and with some careful planning, the packaging design engineer will be able to successfully bring the medical device from concept to end user in a safe usable condition.
Thurs, Dec 7, 2017 (All day)
Duration: 40 Minutes
Sponsored by: Nelson Laborartories LLC
Plastic materials are used with increasing frequency in the medical/healthcare market. Keeping up with the various requirements needed to service this industry is daunting, as the rules are in a constant state of change. This webinar is designed to highlight the key characteristics of materials used for medical/healthcare applications and manufacturability considerations.
Wed, Dec 5, 2017 (All day) - Wed, Dec 5, 2018 (All day)
Duration: 30 Minutes
Sponsored by: Xcentric Mold
The “New” EU Medical Device Regulations: A Game Changer for European Medical Device Companies?
After years of speculation, discussion and debate, the new Medical Device Regulation (“new MDR”) and corresponding In Vitro Diagnostic Regulation (IVDR) were published in May 2017.
This 3-part webinar series will provide an overview of the new MDR focusing on the thinking that lead to them and the thinking to prepare for them. Similarities and differences compared to US regulatory and quality requirements will also be discussed emphasizing the actions that attendees should take now to be ready for 2020 and beyond.
Tues, December 12 - Thurs, December 14 - 02:00 pm each day
Duration: 60 Minutes
Sponsored by: EtQ
Turning User Needs into Design Inputs for Medical Devices
With consumers today accustomed to having sleek, user-friendly technology at their fingertips, it’s increasingly important for medical technology to meet the same standards for usability and exceptional user experiences. As such, medical device designers today need a deep understanding of user needs and how to translate them into user-centered attributes in the finished device, but gaining those insights can be tricky. Join Carolyn Rose and Craig Scherer of the medtech design and development firm Insight Product Development for advice on how to uncover user needs and turn them into design inputs for your next innovative medical device.
Thurs, Dec 14, 2017 - 2:00 pm
Duration: 60 Minutes
Jumpstart Your Career in Medtech
Medtech is a great industry in which to stake out a career, with salaries far above the national average for all occupations and high demand for skilled employees. But that doesn’t mean medtech professionals can put their careers in cruise control. To maximize your earning potential and keep the promotions coming, you need to be proactive. Whether you’re looking to move your career forward or get your foot in the door at a medical device or diagnostics company, we’ll have tips and tricks to help you get ahead in our upcoming webinar
Tues, Nov 14, 2017 - 02:00 pm
Duration: 60 Minutes
New FDA Expectations for Endotoxin Testing
New FDA guidance documents changes the requirements for bacterial endotoxin testing of medical devices. This webinar will cover the four key points that need to be addressed when submitting a (510(k)). Information will also be presented on the test methods, endotoxin limits, and sampling plans.
Thurs, Oct 26, 2017 (All day)
Duration: 15 Minutes
Sponsored by: Nelson Laborartories LLC
Improving Compliance with Increased Global Regulations
Today’s medical device companies must deal with increased product complexity and evolving global regulations. To deliver cutting-edge solutions, companies must comply with quality management system requirements like ISO 13485:2016, while meeting corporate and production objectives. Medical device companies strive to improve patients’ lives by leveraging the latestquality management systems (QMS) to deliver innovative solutions to market while maintaining compliance with the FDA and ISO regulations. Using outdated document-centric QMS solutions hinders product development, quality, and production processes. How can you improve compliance and performance?
Wed, Oct 4, 2017 - 02:00 pm
Duration: 60 Minutes
Sponsored by: Arena Solutions
This three-day webinar will provide engineers and QA/QC/RA managers with an overview of medical device and pharmaceutical industry trends, updates, and anticipated changes. Four major topics will be covered in three days, including: biocompatibility assessments, sterilization methodologies, packaging integrity testing, and medical device cleanliness testing.
Learn the most up-to-date information about these topics from the Nelson Labs’ experts who sit on the domestic and international committees that set the standards for the industry. These experts understand the day-to-day regulations that impact manufacturers and will be providing relevant, current information for attendees. Come prepared with questions, as ample time for your questions will be provided at the end of each webinar.
Tues, September 26 - Thurs, September 28 - 02:00 pm each day
Duration: 60 Minutes
Sponsored by: Nelson Laboratories
IC-DISC basics. Tax Benefits for US Based Exporters
This webinar an introductory overview of the elements of an Interest Charge Domestic International Sales Corporation (IC-DISC) and a discussion of the profile of companies who might benefit from such a structure.
Wed Sep 6, 2017 (All day)
Duration: 30 Minutes
Sponsored by: Sil-Pro
How to Keep Pace with Change in Med-Tech: Industry Challenges and Manufacturing Solutions
Find out how the medical device market can be prepared to innovate faster and more efficiently through the use of closed-loop manufacturing processes. See how Siemens helps you to cope with this increased rate of innovation, to manage product changes as a set of data instead of documents.Learn how your peers have succeeded in this changing environment by focusing on improved product outcomes while simultaneously supporting shorter innovation cycles. See how they employ closed-loop integrated systems that allow for real-time decision-making, based on real intelligence.
Tue, Jul 18, 2017 - 02:00 pm - Wed, Jul 18, 2018 - 03:00 pm
Duration: 60 Minutes
Sponsored by: Siemens PLM Software
What You Need to Know About Establishing a UDI System
Are You Ready to Embrace a UDI System? This webinar is perfect for you if you're a medical device manufacturer or health care distributor. Your company’s success depends on meeting the challenging demands of your industry. Such challenges include regulatory compliances, strict quality assurance requirements, short product life cycles, and multiple subcontractors.
Wed, Jun 7, 2017 (All day) - Thu, Jun 7, 2018 (All day)
Sponsored by: Southeast Computer Solutions
Medical Device Disinfection for Reprocessing Products for US and EU
This webinar is designed for engineers, quality assurance personnel, microbiologists, and marketers of reusable medical device manufacturers to deepen their knowledge about disinfection validation methods for reprocessed devices. Specifically, attendees will better understand disinfection validation standards and practices in the United States and Europe: US FDA Guidance from 2015, AAMI TIR12, AAMI TIR30, ISO15883, among others. Validation techniques and information regarding chemical, thermal, and A0 disinfection testing will be explained.
Thu, Jun 1, 2017 (All day)
Duration: 15-minutes
Sponsored by: Nelson Laboratories
Considerations for Third-Party Reprocessing Of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable healthcare providers to maintain high-quality patient care while saving on costs and reducing medical waste. This webinar will navigate through the required validation aspects to reprocess single-use devices safely and effectively.
Thu, Mar 30, 2017 (All day) - Sat, Mar 30, 2019 (All day)
Duration: 20-minutes
Sponsored by: Nelson Laboratories
The Power of Extractable/Leachable Chemistry Testing for Medical Devices
This presentation will teach you the three most important points of extractable/leachable chemistry testing for medical devices: how it will save you time and money, how it provides detailed information that protects patient safety, and how it will keep you at the front of an evolving approach to the evaluation of biocompatibility.
Thu, Dec 8, 2016 (All day)
Duration: 35-minutes
Sponsored by: Nelson Laboratories
Changing a Colorant in an Approved Medical Device, What Should I Know?
In this webinar we will examine the unique challenges colorants pose to medical devices, including FDA's current position on changing a colorant or pigment. The webinar will cover topics such as possible impacts to human health, how testing can mitigate risk to patient, toxicological risk assessment and choices available for chemical analysis.
Thu, Oct 27, 2016 (All day)
Duration: 30-minutes
Sponsored by: Nelson Laboratories
How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance
This three day course will incorporate the new US FDA guidance on biocompatibility into the three main steps in developing a Biological Safety Evaluation (BSE): Biological Evaluation Plan (BEP), Testing Options, and Biological Evaluation Report (BER). Composed of three one-hour presentations followed by Q&A sessions, the course will cover each step in developing a BSE in detail. This course will provide insight into regulatory expectations when it comes to evaluating device safety.
Tue, Aug 30, 2016 - 02:00 pm - Thu, Sep 1, 2016 - 03:00 pm
Duration: 60-mins per day
Sponsored by: Nelson Laboratories
When Do I Really Need to Perform an Ethylene Oxide Requalification?
One of the first questions that comes to mind after completing an EO sterilization qualification is, "When do I need to perform a requalification study, and what will that study entail?" Maintaining the validated state of a sterilization cycle and ensuring the process consistently and continually delivers the desired SAL is of utmost importance. This presentation takes a comprehensive look at the typical validation approach, the factors that determine when requalification is necessary, and how the expectations in ANSI/AAMI/ISO 11135 have changed in recent years regarding requalification.
Thu, Jul 21, 2016 (All day)
Duration: 30-minutes
Sponsored by: Nelson Laboratories