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Date/Time
Date(s) - 10/07/2019 - 10/10/2019
All Day

Location
Frankfurt Marriott Hotel

Categories

*** NEW COURSE UPDATES ***

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

Date: 7 – 8 October 2019
Price: $1,650 USD (early registration discount of $1,375 USD ends Friday, 16 August 2019)

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 need to have 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 is covered and attendees will 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 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.

Register for both Course A & Course B and save!

Date: 7 – 10 October 2019 
Price: $2,650 USD (early registration discount of $2,190 USD ends Friday, 16 August 2019)

Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two-Day Certification
Date: 9 – 10 October 2019
Price: $1,650 USD (early registration discount of $1,375 USD ends Friday, 16 August 2019)

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!

Date: 7 – 10 October 2019 
Price: $2,650 USD (early registration discount of $2,190 USD ends Friday, 16 August 2019)

Event Details

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 within 24 months. Notice of cancellation must be received in writing by 20 September 2019.  If registrant's preferred payment method is via invoice, payment must be paid in full by 23 August 2019 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 $ 2,650.00
Course A $ 1,650.00
Course B $ 1,650.00

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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
Course Objectives Upon course completion, attendees will be able to:
  • Apply the principles 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 EU's 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!
7 October, 2019 8 October, 2019
8:00-8:30 Check-In 8:30-10:00 Biological Tests: What Manufacturers Should Know
8:30-8:45 Introduction to NAMSA's Certification Program 10:00-10:15 Break
8:45-9:30 Historical Review of Biocompatibility 10:15-11:15 Biological Tests (cont.)
9:30-10:30 ISO 10993-1: Evaluation and Testing Within a Risk Management Process 11:15-12:15 Regulatory Agencies' Specific Approach to Biocompatibility
10:30-10:45 Break 12:15-13:45 Lunch
10:45-11:15 ISO 10993-1 (cont.) 13:45-14:30 Developing a Biological Safety Assessment
11:15-12:00 ISO 10993-12: Sample Preparation & Reference Materials 14:30-17:00 Break and Final Exercises
12:00-13:30 Lunch
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.
 
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.
9 October, 2019 10 October, 2019
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
12:15-13:45 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.
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 limited number of sleeping rooms at the Frankfurt Marriott Hotel for the nightly rate of €179.00/single, available until 6 September, 2019.   To book your room, use the online link: NAMSA Training Series or call +49 69 7955 2222, reference "NAMSA Training Series" to book your stay.