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Date/Time
Date(s) - 01/27/2020 - 01/30/2020
All Day

Location
Hilton San Diego Gaslamp Quarter

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: January 27-28, 2020
Price: $1,675 USD (early registration discount of $1,400 USD ends Friday, December 31, 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 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 2-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!

January 27-30, 2020 $2,860 USD (early registration discount of $2,300 USD ends Friday, December 31, 2019)

Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two-Day Certification
Date: January 29-30, 2019
Price: $1,675 USD (early registration discount of $1,400 USD ends Friday, December 31, 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!

January 27-30, 2020 $2,860 USD (early registration discount of $2,300 USD ends Friday, December 31, 2019)

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 December 27, 2019.  If registrant's preferred payment method is via invoice, payment must be paid in full by December 13, 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 Early Registration $ 2,300.00
Course A Early Registration $ 1,400.00
Course B Early Registration $ 1,400.00

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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!
January 27, 2020 January 28, 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.) 12:15-1:45 Lunch
11:15-12:00 ISO 10993-12: Sample Preparation & Reference Materials 1:45-2:30 Developing a Biological Safety Assessment
12:00-1:30 Lunch 2:30-5:00 Break and Final Exercises
1:30-3:00 ISO 10993-18: Chemical Characterization of Materials
3:00-3:15 Break
3:15-5:00 ISO 10993-17 Establishment of Allowable Limits for Leachable Substances
5:00-6:30 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.
January 29, 2020 January 30, 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.) 12:00-1:30 Lunch
11:15-12:15 ISO 10993-17, A Further Discussion 1:30-3:00 Apply Everything You've Learned- Full Biological Safety Workshop
12:15-1:45 Lunch 3:00-3:15 Break
1:45-3:15 Categorization and Scenario Workshops  3:15-4:30  Workshop Group Discussion
3:15-3:30 Break
3:30-4:30 Categorization and Scenario Workshops
*Actual agenda topics are subject to change—all registered attendees will receive updates if changes occur.
Don Pohl, Principal Product Development Strategist, holds a Bachelor’s degree from Ohio State University. Don has over 25 years of experience in the preclinical 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.
Phillip G. Smiraldo, PhDDABT,  Toxicologist, holds a PhD in Molecular and Cellular Biology from the University of Toledo Medical Center (formerly Medical College of Ohio) and a BS in Biology from Bowling Green State University (summa cum laude; with minors in Chemistry and Italian Language). He was a Postdoctoral Fellow at the University of Texas Southwestern Medical Center (awarded two grants to support his research), authored several articles that were published in peer-reviewed journals (regarding his research of DNA repair in mammalian cells), and authored a book chapter appearing in Telomerases: Chemistry, Biology, and Clinical Applications, and has provided several oral presentations. Dr. Smiraldo's timeless experience in the medical device industry encompasses toxicology, biological safety and preclinical study design, as well as extensive preparation of biological and toxicological risk assessments for submission in countries complying with EU and US FDA regulations. Prior to his current position as Toxicologist, he was a Medical Research Scientist and Study Director (NAMSA), overseeing special/custom preclinical functional studies, preclinical safety studies and simulated-use chemistry studies.  Before joining NAMSA, Dr. Smiraldo was a Staff Toxicologist at WIL Research (approximately 2.5 years), where he was a Study Director of preclinical safety studies for pharmaceutical- and chemical-based products.
NAMSA has secured a limited number of sleeping rooms at the Hilton San Diego Gaslamp Quarter for the nightly rate of $215/single, available until January 5, 2020.   To book please call 1-800-HILTONS and reference "NAMSA" or visit the hotel registration website to secure your room.