“Modern Approaches To Assessment Of Bio-Compatibility - ASQ Biomedical NCDG December 6, 2017 Roundtable-2017-12-06

Event Information
Event Name: 
“Modern Approaches To Assessment Of Bio-Compatibility - ASQ Biomedical NCDG December 6, 2017 Roundtable
Event Date: 
12/06/2017 - 7:00pm
Event Location: 
Stellartech Research Corporation, 560 Cottonwood Drive, Milpitas, CA 95035
Event Details
Event Type: 
Event Details: 

ASQ Biomedical, Wednesday Evening, Dec. 6, 2017

Topic: “Modern Approaches To Assessment Of Bio-Compatibility - ASQ Biomedical NCDG December 6, 2017 Roundtable”
Speaker: Audrey Turley, B.S., RM(NRCM), CBA(ASQ), Technical Consultant, Nelson Laboratories, LLC
Moderator: George Marcel, ASQ NCDG
Date and Time: Wednesday, December 6, 2017 from 7:00 PM to 9:00 PM (PST)
Location: Stellartech Research Corporation, 560 Cottonwood Drive, Milpitas, CA 95035
Food: Snacks equivalent to a light meal and beverages are provided at each event at no additional cost.
Email: To be added to or removed from our email list, contact George Marcel (gmarcel@gmail.com)
Registration Link: NCDGDEC2017.eventbrite.com
ONLY Check or Credit Card accepted at door
Questions: For information about this session, contact George Marcel (gmarcel@gmail.com)
Formal discussion and questions will end between 8:30 - 8:45 pm to allow time for networking after the roundtable presentation.
Materials: Handouts provided. Please limit distribution to immediate personal professional use only.
Pricing and registration at https://www.eventbrite.com/e/modern-approaches-to-assessment-of-bio-comp...

Event Description
Topic: This presentation will provide an overview of the most recent updates to the ISO 10993 series, FDA guidance documents touching biocompatibility, and expected changes coming up for EU and CE marks. The overarching strategy for biocompatibility evaluation in light of this rapidly shifting landscape will be outlined, with an emphasis on utilizing a risk-based approach that reduces both cost and testing burden while simultaneously providing enhanced patient safety.
• Updates to guidance documents that emphasize using a risk-based approach to biocompatibility
• Options and strategies to address biocompatibility with an emphasis on different classes of devices
• Examples of where material assessment has dramatically reduced testing burden

Speaker Bio
Audrey Turley has 20 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert having performed all the in vitro tests offered at Nelson Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM and NIH methods), and genotoxicity (Ames and chromosome aberration). Audrey is part of a team at Nelson Laboratories that recently completed round robin testing for an in vitro irritation assay in an effort to gain acceptance by regulatory bodies in the United States and Europe.
Audrey is an active committee member of many working groups with the Association for the Advancement of Medical Instrumentation (AAMI):
• BE/WG 06 – Mutagen, carcinogen, reproduction toxicity
• BE/WG 07 – Systemic toxicity
• BE/WG 08 – Irritation and sensitization
• BE/WG 10 – Implantation
• BE/WG 11 – Allowable limits for leachable substances

Payment Dec 12th Evening Event - $20 to TheGeneral Public

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