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Biological Safety Training—Boston

About

Date/Time

Date(s) - September 13, 2021 - September 16, 2021 All Day

Location

Hotel Commonwealth
500 Commonwealth Ave
Boston, MA 02215

*** In-person training ***

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

Date: September 13-14, 2021
Location: Hotel Commonwealth, 500 Commonwealth Ave, Boston MA, 02215
Price: $1,675 USD (early registration discount of $1,400 USD ends Saturday, July 31, 2021)

The release of ISO 10993-1:2018, the release of 10993-18:2020 and the Medical Device Regulation (MDR) General Safety and Performance Requirements (GSPR) bring new challenges for medical device manufacturers. The industry is experiencing the most drastic updates in the biological evaluation of medical devices since the issuance of the ISO 10993 standards. This course is structured to tackle each of these challenges and provide hands-on experiential learning. It 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 ISO 10993-18: 2020 and 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!

September 13-16, 2021 $2,860 USD (early registration discount of $2,300 USD ends Saturday, July 31, 2021)

 

Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two-Day Certification
Date: September 15-16, 2021
Location: Hotel Commonwealth, 500 Commonwealth Ave, Boston MA, 02215
Price: $1,675 USD (early registration discount of $1,400 USD ends Saturday, July 31, 2021)

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!

September 13-16, 2021 $2,860 USD (early registration discount of $2,300 USD ends Saturday, July 31, 2021)

 

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Biological Safety Training—Boston

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Speaker

Don Pohl

Principal Product Development Strategist

Don holds a Bachelor’s degree from Ohio State University and 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 Smiraldo, PhD, DABT

Toxicologist

Phillip 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.