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Microbiology Workshop – Virtual

About

Date/Time

Date(s) - March 12, 2024
09:00 AM - 04:40 PM CT

VIRTUAL WORKSHOP – US TIME ZONE

 

Date: March 12, 2024
Location: Virtual Training
Time: 9:00 am – 4:40 pm Central Time (CST)
Pricing: Early Registration through February 4, 2024: $500 USD
Regular Registration beginning February 4, 2024: $600 USD

The evolving landscape of reusable medical device cleaning validation creates significant hurdles for MedTech developers. The recent enforcements by the Environmental Protection Agency (EPA) and new AAMI ST98 requirements further add to the challenges developers need to navigate.

Furthermore, Notified Bodies are keen to comprehend the aging process of your device. They seek evidence that your device remains functional, biocompatible, clean and sterile. Therefore, it is essential to explore the necessary strategies that are optimal for meeting these requirements.

NAMSA invites you to join us for our one-day workshop dedicated to tackling these challenges head-on and providing streamlined solutions that meet your specific product needs. Our expert trainers provide hands-on experience and valuable insights to help you navigate the complexities of reprocessing and maintain compliance with industry best practices.

Upon completion, attendees will be able to:

  • Adapt to the new AAMI ST98 requirements and make informed decisions to enhance product quality and regulatory compliance
  • Effectively navigate the evolving landscape of ethylene oxide (EO) sterilization
  • Learn how to effectively manage EO residuals, ensuring compliance with industry standards and best practices for device reprocessing
  • Gain a deep understanding of global regulatory requirements and expectations regarding the end of the device lifecycle

Who Should Attend?

  • Microbiologists involved in the evaluation of Medical Devices
  • Attendees of NAMSA Course A or B and desire more hands-on experience with microbiology
  • Regulatory Affairs and Quality Assurance Professionals
  • Research, Design and Manufacturing Engineers
  • Product Managers, Laboratory Managers

NOTE: If you are working from home during this time, please ensure to include your home address under the shipping field during registration. Course materials will be shipped to the shipping address you provide.

Our security measures require that your credit card billing address match your profile address.

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com. 

 

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Microbiology Workshop – Virtual

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Agenda

Speaker

Joe Brinkman

Senior Technical Sales Advisor

Joe Brinkman is a seasoned professional with over two decades of expertise in the field of industrial microbiology. He honed skills in ethylene oxide and gamma sterilization validation, cleanroom monitoring and management, bacterial endotoxin testing, and biocompatibility. He specialized in managing validations for complex devices with critical timelines, including ethylene oxide, gamma, and E-beam sterilization, cleaning validation, and cleanroom monitoring and management. A particular focus of Joe’s expertise lies in cleanroom emergency control, and problem investigation; reflecting his commitment to ensuring the highest standards of safety and compliance. Currently, Joe is engaged in a Senior Technical Sales Advisor role at NAMSA and participates in training activities for industrial microbiology, leveraging his wealth of experience to impart valuable insights to professionals in the field.

Staci L. DeMoss, B.S.

Principal Validation Scientist

Staci is a technical expert in medical device processing offering over 20 years of experience in single-use and reusable device (re)processing including medical device cleaning, disinfection and sterilization.  Her primary focus is assisting medical device manufacturers in the creation and validation of (re)processing instructions to ensure regulatory compliance.   Staci worked in both quality and sterility assurance roles, supporting medical device manufacturing, before joining NAMSA in 2008.

Staci has a bachelor’s degree in Chemical Engineering and is a member of the Advancement of Medical Instrumentation (AAMI).