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SDRAN: FDA Feedback from Recent Biocompatibility Submissions

January 19, 2021 @ 6:00 pm - 7:45 pm

Program Speaker:

Thor S. Rollins
Director, Toxicology and E&L Consulting at
Nelson Laboratories, LLC

 

Event Agenda:
DATE: Wednesday, 20 January 2021
TIME*: 6:00 – 6.05 PM – Welcome – Erica Livingston & Sasi Mudumba
6:05 – 6.30 PM – Annual Meeting
6:30 – 7.30 PM – Program Presentation
7:30 – 7:45 PM – Q & A
* Times are approximate

 

LOCATION: This is an ONLINE event. After the registration, you will receive a Zoom link to join
the event.

 

Click here to register for this event.

 

Program Topic:
Nelson Labs has a great deal of experience performing biocompatibility and extractable and
leachable (E&L) studies for regulatory submissions—including the US FDA. With this
experience, Nelson Labs has followed FDA feedback trends on recent submissions and
developed specific procedures to address this feedback.
In this presentation, Thor will cover the recent FDA biocompatibility and E&L feedback and
concerns and will discuss approaches to address these concerns before the submission
process.

 

Speaker Biography:
Thor Rollins is a certified microbiologist who specializes in the selection and execution of in
vitro and in vivo biocompatibility tests. Currently he is the Director, Toxicology and E&L
Consulting at Nelson Laboratories, LLC. He actively speaks on biocompatibility related topics
through external seminars, webinars, conferences, and trade shows. Thor has published
multiple peer-reviewed articles and white papers regarding the proper testing of medical
devices.
Thor is a participating member of all AAMI (Association for Advancement of Medical
Instrumentation) TC 194 and ISO 10993 committees. He plays an active role with the FDA
and other regulatory committees in developing standards concerning biocompatibility
methods; he is also a voting member regarding changes to those standards. As one of a select
group of experts in the industry, Thor’s participation on these committees offers him unique
insight into industry changes which he uses to help prepare clients for changes in testing.

 

Registration Information:
Please click here
Online registration ends Tuesday, 19 January 2021
$10.00 SDRAN Member $15.00 Non-Member

For Questions Email: Programs.committee@sdran.org

Details

Date:
January 19, 2021
Time:
6:00 pm - 7:45 pm
Event Category:

Venue

Online