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Date/Time
Date(s) - 03/19/2018 - 03/22/2018
All Day

Location
Hotel Sofitel

Categories

Course A: Biocompatibility of Medical Devices- Two Day Certification Course

March 19-20, 2018

$1,500 (early registration pricing of $1,300 ends Monday, February 19, 2018)

This course is geared toward those who require a working knowledge of biocompatibility. The objective of the course is to teach participants how to use standards to establish a biological safety evaluation plan, including how to document and implement their plan. Use of risk assessment is covered and participants will practice evaluating biological risk. Both days are structured to be hands-on; attendees must attend and complete all exercises to be certified as a biological safety specialist.

Register for both Course A & Course B and save!

March 19-22, 2018
$2,400 (early registration pricing of $2,150 ends Monday, February 19 2018)


NEW! Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two Day Certification

March 21-22, 2018
$1,500 (early registration pricing of $1,300 ends Monday, February 19, 2018)

Newly updated, this 2-day training course is designed for those who have received certification in the NAMSA Training Series Biocompatibility of Medical Devices Two Day Certification Course. Objectives of this course include practice beyond the basics of ISO 10993 with increased practical application and updated workshops. In addition to traditional medical devices, we will address combination products and resorbable materials. Participants will not only learn how to assess their device for biological risks but also understand when testing is not necessary. Utilizing ISO 10993-17, attendees with actively calculate safe limits with practical chemical characterization data. Additionally, hands-on, instructor-led workshops will provide an opportunity to work with real-world medical device studies to help provide solutions and an understanding of how to present data in various regulatory submissions. Participants will walk away with the knowledge of how to plan a strategy to efficiently manage potential obstacles.

Register for both Course A & Course B and save!

March 19-22, 2018
$2,400 (early registration pricing of $2,150 ends Monday, February 19 2018)

Event Details

If you work for a company located in France, and would like to register, please do not Pay by Credit card, select Pay Offline.  You will be contacted for payment.

Si vous travaillez pour une entreprise située en France, et que vous voulez vous enregistrer, veuillez ne pas payer avec une carte de crédit mais sélectionnez l’option « pay offline ». Vous serez contacté ultérieurement pour le payement.

Included in registration:
  • Course Material
  • Lunch
  • Certificates of completion for participants
  • Opportunity to interact with instructors, all of whom are experts in the medical device industry
  • Opportunity to interact with peers from the medical device industry
Fees are non-refundable but are transferable to a colleague within the same company or may be credited toward a future NAMSA Training Event. Notice of cancellation must be received in writing by  If registrant's preferred payment method is via invoice, payment must be paid in full by February 28, 2018 to ensure registration.
*By registering for this event, you agree to also receive further information from NAMSA.*
Ticket Type Price Spaces
Course A & B $ 2,150.00
Course A $ 1,300.00
Course B $ 1,300.00

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  • Regulatory Affairs and Quality Assurance Professionals
  • Research, Design and Manufacturing Engineers
  • Microbiologists and Chemists involved in the evaluation of Medical Devices
  • Product Managers, Laboratory Managers
  • Process Development and System Engineers
  • Toxicologists and Biological Safety Specialists
  • Those who need continuing education for RAPS Certification
Course Objectives
  • Understand and apply ISO 10993-1 and the FDA Guidance on its use. Know how to use the ISO documents to locate information that you need.
  • How to apply Materials characterization, and more importantly learn how to use the information to understand biological safety.
  • ISO 14971 and how to use it. Learn how to use ISO 10993-1 as a tool for hazard identification.
  • Learn the difference between evaluation and testing. Recognize when testing is absolutely necessary and how to avoid unnecessary testing.
  • Understand what tests to select and how to choose among various options. Answer the question:  When is testing not the only option?
  • Learn how to develop a program that guides your device on the regulatory path and reduces your time to market.
  • Gain knowledge on the principles of toxicology, FDA consensus standards, and Good Laboratory Practices.
  • Practice how to execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan.
Join us at the end of the first day for a networking reception!
March 19, 2018
March 20, 2018
8:00-8:30 Check-In 8:30-10:15 ISO 10993-17 Allowable Limits
8:30-8:45 Introduction to NAMSA's Certification Program 10:15-10:30  Break
8:45-9:30 Historical Review of Biocompatibility: 1985-2016 10:30-11:15 ISO 14971-Risk Assessment
9:30-10:30 ISO 10993-1 11:15-12:15 Biological Tests: What Manufacturers Should Know
10:30-10:45 Break 12:15-13:15  Lunch
10:45-12:00 FDA's Approach to Biocompatibility 13:15-14:30 Biological Tests: What Manufacturers Should Know  (cont'd)
12:00-13:00 Lunch 14:30-17:00 Break and Final Exercise
13:00-14:30 Materials Characterization
14:30-14:45 Break
14:45-15:45 Developing a Biological Safety Evaluation Plan
15:45-16:30 Good Laboratory Practices
16:30-17:00 Closing Comment & Questions
17:00-18:30 Evening Reception

*Actual agenda topics are subject to change -- all registered attendees will receive updates if changes occur.
Course Objectives
  • Gain a deeper understanding of global regulatory expectations for biological safety.
  • Know how to review reports for accurate data and work with a laboratory when unexpected results are reported.
  • Understand evaluating complexities for drug/device combination devices.
  • Familiarization with calculating allowable limits for cancer, chemical mixtures, and assessment of unidentified chemicals.
  • Experience working application with two, real life exercises to calculate allowable limits, experience testing errors and how to mitigate them, and then manage a device from concept to market clearance.
March 21, 2018
March 22, 2018
8:00-8:30 Check-In 8:30-10:15 Materials Characterization, Biodegradation and Resorbable Materials
8:30-8:45 Introduction 10:15-10:30 Break
8:45-10:00 Top Questions we Still Have After Course A 10:30-12:00 Biological Evaluation of Combination and Tissue Based Products
10:00-10:30 All the Biological Effects for Which I Don't Test 12:00-13:30 Lunch
10:30-10:45 Break 13:30-15:00 Apply Everything You've Learned-Full Biological Safety Workshop
10:45-11:15 All the Biological Effects for Which I Don't Test (cont.) 15:00-15:15 Break
11:15-12:15 ISO 10993-17, A Further Discussion 15:15-16:30 Workshop Group Discussion
12:15-13:30 Lunch
13:45-15:15 Categorization and Scenario Workshops
15:15-15:30 Break
15:30-16:30 Categorization and Scenario Workshops
*Actual agenda topics are subject to change -- all registered attendees will receive updates if changes occur.
don-pohl Don PohlManager of Biological Safety and Validation, holds a Bachelor’s degree from Ohio State University.  Don has over 20 years of experience in the pre-clinical evaluation of medical devices for biological safety.  During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation.  He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.


  Dr. Nicolas Martin, Senior Medical Research Scientist, joined NAMSA in 2012. He holds an Engineer Degree in General Chemistry from École Supérieure de Chimie Physique Électronique de Lyon (France) and a PhD in Organic Chemistry from the University of Birmingham (UK). His expertise includes organic, analytical and industrial chemistry, material and chemical characterization, with over 8 years research laboratory experience.
Dr. Sylvie Framery, Senior Principal Medical Research Scientist, holds a Ph.D. in Biology from the University of Rennes (France). Her primary expertise is in the field of Biocompatibility/Toxicology, with more than 10 years of laboratory experience in NAMSA, in Lyon France. She has spoken and published in several conferences /Seminars and international newspapers. Today, she serves as Consultant specializing in biomaterial safety issues.