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Date/Time
Date(s) - 03/30/2020 - 04/02/2020
All Day

Location
Radisson Blu Hotel, Lyon

Categories

*** REGISTER TO WIN *** 

All early-bird registrations will be entered to win a copy of the newly released “Biocompatibility and Performance of Medical Devices, Second Edition”edited by Jean Pierre Boutrand.

*** NEW COURSE UPDATES ***

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

Date: 30-31 March 2020
Price: $1,815 USD (early registration discount of $1,510 USD ends Saturday, 29 February 2020)

The recent release of ISO 10993-1:2018 and the upcoming Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) bring new challenges for medical device manufacturers. This course is structured to be hands-on and is designed for those who require a working knowledge of biocompatibility or are looking to update and sharpen their skills. Participants can expect to learn how to use standards to establish a biological safety evaluation plan and document and implement their plan. Use of material/chemical characterization and risk assessment will be highlighted, as will real-world exercises to practice evaluating biological risk. (In order to be certified as a biological safety specialist, participants must attend and complete all exercises over the two-day course).

Course Objectives

Upon course completion, attendees will be able to:

  • Apply the principles of ISO 10993-1:2018 to their particular challenges with medical device biocompatibility
  • Discuss the FDA guidance for biological safety and distinguish where the FDA and other regulatory bodies differ
  • Prepare to upgrade device technical documentation to meet the European Union’s (EU) MDR 2017/745 GSPR
  • Answer the question: When is testing not the only option?
  • Distinguish the difference between evaluation and testing. Recognize when testing is absolutely necessary and how to avoid unnecessary testing.
  • Select chemical and biological tests and understand how to choose among various methods
  • Utilize material/chemical characterization information with the use of toxicological risk assessment to demonstrate biological safety
  • Develop a program that guides your device on the regulatory path and reduces time to market
  • Practice how to execute your plan from development to completion and how to schedule and document the implementation of your biocompatibility plan

 Register for both Course A & Course B and save!

30 March – 2 April 2020 $2,915 USD (early registration discount of $2,410 USD ends Saturday, 29 February 2020)

Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two-Day Certification
Date: 1-2 April 2020
Price: $1,815 USD (early registration discount of $1,510 USD ends Saturday, 29 February 2020)

This two-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 Table A.1 in 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 will actively calculate safe limits with practical chemical characterization data. Additionally, instructors will provide an opportunity to work with case studies on real medical devices and provide solutions and an understanding of how to present data in a submission during the hands-on workshops. Participants will walk away with the knowledge of how to plan a strategy to endure potential obstacles.

Course Objectives

Upon course completion, attendees will be able to:

  • Distinguish global regulatory expectations for biological safety.
  • Review reports for accurate data and work with a laboratory when unexpected results are reported.
  • Evaluate complexities for drug/device combination devices.
  • Calculate allowable limits for cancer, chemical mixtures and assessment of unidentified chemicals.
  • Apply skills gained from two, real-life exercises to calculate allowable limits and experience testing errors and how to mitigate them, as well as manage a device from concept to market clearance.

Register for both Course A & Course B and save!

30 March – 2 April 2020 $2,915 USD (early registration discount of $2,410 USD ends Saturday, 29 February 2020)

Event Details

Included in registration:  
  • Course Material
  • Breakfast and 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 within 24 months. Notice of cancellation must be received in writing by February 29, 2020.  If registrant's preferred payment method is via invoice, payment must be paid in full by February 14, 2020 to ensure registration. If making a credit card payment, note that your profile address must match the credit card address on file.
Ticket Type Price Spaces
Course A & B Early Registration $ 2,410.00
Course A Early Registration $ 1,510.00
Course B Early Registration $ 1,510.00

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Who should attend:  
  • 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
Upon course completion, attendees will be able to:  
  • Apply the principles of ISO 10993-1:2018 to their particular challenges with medical device biocompatibility.
  • Discuss the FDA guidance for biological safety and distinguish where the FDA and other regulatory bodies differ.
  • Prepare to upgrade device technical documentation to meet the European Union’s (EU) MDR 2017/745 GSPR.
  • Answer the question: When is testing not the only option?
  • Distinguish the difference between evaluation and testing. Recognize when testing is absolutely necessary and how to avoid unnecessary testing.
  • Select chemical and biological tests and choose among various methods.
  • Utilize material/chemical characterization information with the use of toxicological risk assessment to demonstrate biological safety.
  • Develop a program that guides your device on the regulatory path and reduces your time to market.
  • 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!
30 March 2020 31 March 2020
8:00-8:30 Breakfast Buffet and Check-In 7:30-8:30 Breakfast Buffet
8:30-8:45 Introduction to NAMSA's Certification Program 8:30-10:00 Biological Tests: What Manufacturers Should Know
8:45-9:30 Historical Review of Biocompatibility 10:00-10:15 Break
9:30-10:30 ISO 10993-1: Evaluation and Testing Within a Risk Management Process 10:15-11:15 Biological Tests (cont.)
10:30-10:45 Break 11:15-12:15 Regulatory Agencies' Specific Approach to Biocompatibility
10:45-11:15 ISO 10993-1 (cont.) 12:15-13:45 Lunch
11:15-12:00 ISO 10993-12: Sample Preparation & Reference Materials 13:45-14:30 Developing a Biological Safety Assessment
12:00-13:30 Lunch 14:30-17:00 Break and Final Exercises
13:30-15:00 ISO 10993-18: Chemical Characterization of Materials
15:00-15:15 Break
15:15-17:00 ISO 10993-17 Establishment of Allowable Limits for Leachable Substances
17:00-18:30 Evening Reception
*Actual agenda topics are subject to change—all registered attendees will receive updates if changes occur.
Upon course completion, attendees will be able to:  
  • Distinguish global regulatory expectations for biological safety.
  • Review reports for accurate data and work with a laboratory when unexpected results are reported.
  • Evaluate complexities for drug/device combination devices.
  • Calculate allowable limits for cancer, chemical mixtures and assessment of unidentified chemicals.
  • Apply skills gained from two, real-life exercises to calculate allowable limits and experience testing errors and how to mitigate them, as well as manage a device from concept to market clearance.
1 April 2020 2 April 2020
8:00-8:30 Breakfast Buffet and Check-In 7:30-8:30 Breakfast Buffet
8:30-8:45 Introduction 8:30-10:15 Materials Characterization, Biodegradation and Resorbable Materials
8:45-10:00 Top Questions we Still Have After Course A 10:00-10:30 Break
10:00-10:30 All the Biological Effects for Which I Don't Test 10:30-11:15 Biological Evaluation of Combination and Tissue Based Products
10:30-10:45 Break 11:15-12:00 Regulatory Agencies' Specific Approach to Biocompatibility
10:45-11:15 All the Biological Effects for Which I Don't Test (cont.) 12:00-13:30 Lunch
11:15-12:15 ISO 10993-17, A Further Discussion 13:30-15:00 Apply Everything You've Learned- Full Biological Safety Workshop
12:15-13:45 Lunch 15:00-15:15 Break
13:45-15:15 Categorization and Scenario Workshops  15:15-16:30  Workshop Group Discussion
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.
Sylvie Framery, Senior Principal Biological Safety Scientist, holds a Ph.D. in Biology. She has been working for more than 15 years with NAMSA, with experience primarily focused on the pre-clinical evaluation of medical devices. Based in the French NAMSA Laboratory, she serves as Subject Matter Expert in support of Medical Research Managers and Technical Advisors. She is the author of multiple documents including Biological Safety Plans, Biological Risk Assessments, Toxicological Risk Assessments, Gap Analyses, and Expert Reports as well. She provides regularly training sessions in Europe to medical devices manufacturers and Notified Bodies. She provides consulting services to manufacturers with biocompatibility projects for worldwide market approvals and supports them during on-site meetings with regulatory authorities. She is also an active member of the ISO/TC 194 committee.
   Dr. Nicolas Martin, Principal 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.
NAMSA has secured a small room block for attendees. To book your accommodations, please click here or contact the Radisson Blu Hotel +33 (0)4 78 63 55 00 and reference the "NAMSA Training Series".