LIVE Webinar: How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance

Register HERE for the three-day live webinar series “How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance” presented by Nelson Laboratories’ experts: Thor Rollins, Sarah Campbell, and Audrey Turley.

This three-day webinar will incorporate the new US FDA guidance on biocompatibility into the three main steps in developing a Biological Safety Evaluation (BSE): Biological Evaluation Plan (BEP), Testing Options, and Biological Evaluation Report (BER). Composed of three one-hour presentations followed by Q&A sessions, the webinar will cover each step in developing a BSE in detail. This webinar will provide insight into regulatory expectations when it comes to evaluating device safety.

The presenters for this three day webinar provide a combined 50 years of experience in their field of expertise. Thor Rollins is a leading biocompatibility expert and has worked closely with medical device companies and the FDA for over 15 years. Dr. Sarah Campbell is a board certified Toxicologist with an extensive 17 year background in practicing and using analytical chemistry for toxicological evaluation. This combination of expertise is important to in order to handle the important aspects of material/chemical characterization and toxicological risk assessment. Audrey Turley has 20 years of experience working in research, laboratory, and test design functions in the medical device industry.

DAY 1: DEVELOP A BIOLOGICAL EVALUATION PLAN (BEP)

The new FDA guidance document for ISO 10993-1 focuses on a risk based approach to biocompatibility. The first step is to develop a BEP. This webinar will go over the thought process and information needed to develop a useful testing plan.

Date: August 30, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Thor S. Rollins, B.S., RM (NRCM)
Senior Scientist

 DAY 2: UNDERSTANDING TEST OPTIONS

Justifying out of testing using chemical characterization vs performing full biocompatibility testing. The first important step in determining the risk of a medical device to a patient is to know and understand your materials and processes. This webinar will go over the steps in evaluating device materials and an extractable/leachable chemical testing needed to demonstrate biocompatibility.

Date: August 31, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Sarah Campbell, PhD, DABT
Toxicologist

DAY 3: SUMMARIZE ALL YOUR FINDINGS IN A BIOLOGICAL EVALUATION REPORT (BER)

The ISO 10993-1 and new FDA guidance document asks you to write a BER to demonstrate that the identified risks have been mitigated. We will go over the information needed and the important points that should be included in the report.

Date: September 1, 2016
Time: 11:00 AM PDT | 2:00 PM EDT
Duration: 60-minutes

PRESENTED BY:

Audrey Turley, B.S., RM (NRCM), CBA (ASQ)
Research Scientist

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s