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Modern Approaches to Assessment of Bio-compatibility - ASQ Biomedical NCDG December 6, 2017 Roundtable

ASQ Biomedical Division NCDG - Northern California Discussion Group

Wednesday, December 6, 2017 from 7:00 PM to 9:00 PM (PST)

Modern Approaches to Assessment of Bio-compatibility...

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Ticket Type Sales End Price Fee Quantity
Online discounted registration
Register by December 5, 2017 11:59 PM to receive this discounted rate.
Dec 5, 2017 $30.00 $0.00
Student & Unemployed discounted online registration
Register by October 24 2017 11:59 PM to receive this discounted rate.
Dec 5, 2017 $20.00 $0.00
December 6, 2017 Event (Online & At Door)   more info Not Started $40.00 $0.00

Share Modern Approaches to Assessment of Bio-compatibility - ASQ Biomedical NCDG December 6, 2017 Roundtable

Event Details

 

The Northern California Discussion Group of the ASQ Biomedical Division Presents: 

Modern Approaches to Assessment of Biocompatibility

Wednesday, December 6, 2017, 7:00 to 9:00 pm

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

 

Featured Speaker:

Audrey Turley, B.S., RM(NRCM), CBA(ASQ), Technical Consultant, Nelson Laboratories, LLC

Image result for audrey turley

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

 

Moderator:   George Marcel, ASQ NCDG

Location: Stellartech Research Corporation, 560 Cottonwood Dr., 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. 

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  Webinar link for December 6, 2017  Roundtable (No cost remote login - Handouts not provided)

  https://attendee.gotowebinar.com/register/6807598041417030657

 

 

 

 


 


 


Have questions about Modern Approaches to Assessment of Bio-compatibility - ASQ Biomedical NCDG December 6, 2017 Roundtable ? Contact ASQ Biomedical Division NCDG - Northern California Discussion Group

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When & Where


Stellartech Research Corporation
560 Cottonwood Drive
Milpitas, CA 95035

Wednesday, December 6, 2017 from 7:00 PM to 9:00 PM (PST)


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Organizer

ASQ Biomedical Division NCDG - Northern California Discussion Group

§The Northern California Discussion Group (NCDG) is the regional ASQ Biomedical Discussion Group.  The Biomedical Division is an industry specific Division of ASQ §  Our Vision  To be the leading authority on quality issues related to the Biomedical Community   Our Mission  To promote the awareness and the use of quality principles, concepts and technologies in the Biomedical Community   www.asq.org/biomed   The local discussion group has a Linked In group (https://www.linkedin.com/groups/1804635) and mailing list as noted above.

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Modern Approaches to Assessment of Bio-compatibility - ASQ Biomedical NCDG December 6, 2017 Roundtable
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