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Events

On-Demand Webinar

Mar
On-Demand Webinar

Event Date: March 14, 2017

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.

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Dec
On-Demand Webinar

Event Date: December 8, 2016

The Power of Extractable/Leachable Chemistry Testing for Medical Devices

This webinar summarizes how extractable/leachable chemistry testing for medical devices can save time and money for manufacturers preparing for a 510(k) submission. A few of the strategies and options are explained for conducting an extractable/leachable chemistry study according to ISO 10993 standards, leading up to case studies that illustrate the power of chemistry testing as an integral part of the biocompatibility evaluation plan.

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Oct
On-Demand Webinar

Event Date: October 27, 2016

Changing a colorant in an approved medical device, what should I know?

In the webinar What Manufacturers Need to Know about Changing a Colorant in an Approved Medical Device, we will examine the unique challenges colorants pose to medical devices, including FDA’s current position on changing a colorant or pigment.

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Sep
On-Demand Webinar

Event Date: September 1, 2016

Day 3: Summarize all your findings in a Biological Evaluation Report (BER): The ISO 10993-1

The ISO 10993-1 and new FDA guidance document asks you to write a BER to demonstrate that the identified risks have been mitigated. We will go over the information needed and the important points that should be included in the report.

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Aug
On-Demand Webinar

Event Date: August 31, 2016

Day 2: Understanding Test Options

Justifying out of testing using chemical characterization vs performing full biocompatibility testing. The first important step in determining the risk of a medical device to a patient is to know and understand your materials and processes. This webinar will go over the steps in evaluating device materials and an extractable/leachable chemical testing needed to demonstrate biocompatibility.

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Aug
On-Demand Webinar

Event Date: August 30, 2016

Day 1: Develop a Biological Evaluation Plan (BEP)

The new FDA guidance document for ISO 10993-1 focuses on a risk based approach to biocompatibility. The first step is to develop a BEP. This webinar will go over the thought process and information needed to develop a useful testing plan.

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Jul
On-Demand Webinar

Event Date: July 21, 2016

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.

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May
On-Demand Webinar

Event Date: May 19, 2016

New Approaches to Assessing Biocompatibility for Medical Devices

The regulatory environment for biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have typically been addressed with biocompatibility testing on animals; however, alternate options are now available using literature research and chemical characterization tests when appropriate to reduce animal testing.

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Nov
On-Demand Webinar

Event Date: November 12, 2015

Water Quality for Pharmaceutical and Medical Device Processes

Water is one of the most widely used raw materials in the MedTech industry; yet water systems are often overlooked as a source of contamination. Register for this webinar to learn the effects water impurities can have and how to select quality water attributes for processes, system qualification, monitoring, and process controls. Attendees will also gain insight into recovering existing water systems, and proper design for new water systems.

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Nov
On-Demand Webinar

Event Date: November 4, 2015

Regulatory Requirements for Packaging Changes

In recent years, the question of how to deal with packaging changes has become a hot topic in the medical device industry. Knowing how to navigate packaging changes and determining what needs to be done to maintain compliance can be a struggle.

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Sep
On-Demand Webinar

Event Date: September 18, 2015

Assurance of Sterility and Sterility Assurance Levels: What’s in the Future?

Currently there is an initiative in the ISO technical committee on sterilization of healthcare products to develop a standard which discusses assurance of sterility. As the content for the ISO standard is developed to represent current and future industry thinking worldwide, several topics have been discussed in detail which will be included in the webinar.

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Aug
On-Demand Webinar

Event Date: August 25, 2015

Updates & Trends from FDA; Including Recent ISO 10993 News

Allison Komiyama, regulatory consultant will breakdown the FDA’s “A-list” guidance documents and how recent recommendations may impact medical device manufacturers. Biocompatibility expert Thor Rollins of Nelson Labs will provide insights on biocompatibility testing and where the ISO/TC-194 working group plans to take the ISO 10993 standard in the future.

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Jun
On-Demand Webinar

Event Date: June 9, 2015

Understanding Ethylene Oxide Sterilization

This presentation will go through the history, background, and requirements to perform an appropriate ethylene oxide sterilization validation.

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Jun
On-Demand Webinar

Event Date: June 9, 2015

Ethylene Oxide – Navigating Recent Standards Changes and Industry Challenges

This presentation will discuss the impact of changes to the ISO 11135:2014 sterilization standard, as well as revisions to the related AAMI guidance documents (AAMI TIR 14, 15, 16, and 28).

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May
On-Demand Webinar

Event Date: May 6, 2015

Learning From HAIs: Understanding Reprocessing Regulations, Validation & Human Factors

This lecture provides an overview of Hospital Acquired Infections, human factors issues encountered in device design and in the healthcare facility, and how to perform a validation for a reusable medical device for use in the healthcare facility.

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Mar
On-Demand Webinar

Event Date: March 24, 2015

Developing your Packaging Validation Plan

This webinar will highlight the purpose of having a documented validation plan in place prior to performing any package testing. We will also look at regulatory requirements, examine key considerations when designing, manufacturing, packaging, and testing your medical device, and review what needs to be incorporated into each section of the protocol.

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Feb
On-Demand Webinar

Event Date: February 11, 2015

Categorizing Medical Devices Per ISO 10993-1

Learn the latest FDA device classification trends from Nelson Labs biocompatibility expert Thor Rollins.

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Feb
On-Demand Webinar

Event Date: February 10, 2015

Developing a Test Strategy and Plan

This webinar provides a basic overview of considerations for establishing a test strategy and test plans for biocompatibility, sterilization and packaging of healthcare products. We emphasize the importance of this being done early on in the process.

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Dec
On-Demand Webinar

Event Date: December 3, 2014

Rethinking the Big Three: Cytotoxicity, Sensitization, & Irritation

This presentation will examine how the “Big Three” biocompatibility tests (cytotoxicity, sensitization, and irritation) are advancing and what those advancements mean for medical device manufacturers.

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Dec
On-Demand Webinar

Event Date: December 3, 2014

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.

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Oct
On-Demand Webinar

Event Date: October 30, 2014

The Big Three: Cytotoxicity, Sensitization & Irritation at MD&M Minneapolis

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.

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Oct
On-Demand Webinar

Event Date: October 23, 2014

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.

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Aug
On-Demand Webinar

Event Date: August 12, 2014

The Power of Chemical Characterization to Assess Changes webinar

This presentation will discuss chemical characterization and how these test methods can help evaluate the impact of a change to the overall biocompatibility of the device.

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May
On-Demand Webinar

Event Date: May 22, 2014

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.

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Feb
On-Demand Webinar

Event Date: February 11, 2014

Healthcare Reprocessing of Medical Devices and Human Factors Debrief

The reusable medical device industry is facing challenges regarding device design considerations and usability. The demand for more complex devices has led to the introduction of devices that are difficult to reprocess.

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Sep
On-Demand Webinar

Event Date: September 18, 2013

Particulates: Their Role in the Pharmaceutical Industry

Particulate Matter Testing: Testing requirements and methods for intravenous and parenteral products.

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Aug
On-Demand Webinar

Event Date: August 29, 2013

Microbiology Testing for Non-sterile Products

Microbial testing is an important tool used to determine product contamination and risk assessment criteria.

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Aug
On-Demand Webinar

Event Date: August 28, 2013

Establishing Bioburden Alert and Action Levels

Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product.

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May
On-Demand Webinar

Event Date: May 30, 2013

Sterility Testing Using an Isolator

Product Sterility Testing: Basic testing requirements and methods. This presentation will cover: • Isolator use • Isolator package validation requirements • Bacteriostasis and Fungistasis (B/F) requirements • Packaging constraints/issues • Failure investigations

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Oct
On-Demand Webinar

Event Date: October 10, 2012

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

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.

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Oct
On-Demand Webinar

Event Date: October 10, 2012

Regulatory Considerations for Managing Changes in Packaging Materials & Packaging Test Methods for Validation

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.

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Sep
On-Demand Webinar

Event Date: September 26, 2012

Ethylene Oxide Sterilization- Batch Release Method

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.

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Mar
On-Demand Webinar

Event Date: March 21, 2012

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.

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Feb
On-Demand Webinar

Event Date: February 29, 2012

Cleaning Validations of Reusable Medical Devices

Cleaning Validation of Reusable Medical Devices This 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.

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Nov
On-Demand Webinar

Event Date: November 30, 2011

Tissue Processing Validation Concepts

The intent of the webinar is to provide those who perform or review process validations with the concepts and knowledge needed to properly set up the validation and interpret the data.

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Jun
On-Demand Webinar

Event Date: June 29, 2011

Particulates- Their Role in the Medical Device Industry

Particulates that may be present on intravenous medical devices such as guidewires, catheters, and stent delivery systems pose potential health risks to patients. This webinar is aimed toward companies that develop such products or manufacture other cardiovascular medical devices or devices that are likely to come in contact with a patient’s bloodstream.

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Mar
On-Demand Webinar

Event Date: March 30, 2011

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.

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Dec
On-Demand Webinar

Event Date: December 1, 2010

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. This training starts with discussing the standards.

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Oct
On-Demand Webinar

Event Date: October 27, 2010

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.

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Aug
On-Demand Webinar

Event Date: August 18, 2010

Ethylene Oxide Sterilization Validation

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.

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