Designing Medical Devices with Cleanliness in Mind

    /Kierstan  /Andrascikspeaker of compliance global
    Speaker: Kierstan Andrascik
    Duration: 60 Minutes
    Product Code: 700183
    Level: Beginner
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overview

Cleanliness is a hot topic in the medical device industry. The FDA expects medical device companies to validate the cleanliness of their devices. One of the best ways to achieve a clean device is by designing it with cleanliness in mind.

why should you attend

This webinar will provide valuable guidance to medical device manufacturers on design considerations for both single-use and re-usable devices. There are certain design elements that are more difficult to clean and should be avoided whenever possible. With the “right” design, both the manufacturing and cleaning process validation can be simplified.

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Areas Covered

  • Design Requirements Document
  • Single-Use Design Considerations
  • Re-usable Design Considerations
  • Design Elements to Avoid/Minimize
  • Simplifying the Manufacturing Process
  • Simplifying the Cleaning Process

Learning Objectives

  • Why cleaning must be considered during the design phase
  • What design elements should be avoided or minimized
  • What can be done to simplify the manufacturing and cleaning processes

WHO WILL BENEFIT

  • QA/QC Managers and Personnel 
  • Validation Managers and Personnel
  • R&D Professionals
  • Engineering Professionals
  • Compliance Officer
  • Marketing & Sales

SPEAKER

Kierstan Andrascik has worked in the medical device industry for more than 13 years. She founded QVET Consulting in 2009 to assist medical device manufacturers with their validation needs. She specializes in cleaning validations for both new and reprocessed medical devices and has established herself as one of the foremost experts in medical device cleanliness. She also provides guidance in many other areas including sterilization, biocompatibility, packaging, and materials characterization. She has a BS in chemistry and mathematics, and an AS in Engineering from Shepherd University in Shepherdstown, West Virginia.

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This webinar is currently unavailable.Please contact customer support on +1-844-746-4244 for training options that we could offer you and further details about this listing.
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