Date/TimeDate(s) - March 23, 2021 - March 24, 2021
*** VIRTUAL TRAINING ***
Join NAMSA as we launch our NEW virtual Biocompatibility of Medical Devices Training on March 23-24, 2021 (5:00am-2:00pm Central Standard Time U.S./11:00am-8:00pm Central European Time E.U.). Attendees will receive all the perks of NAMSA’s highly sought-after in-person training while in the comfort of their own home or office. This interactive, educational two-day training will also provide open discussion with your industry peers, Q&A with NAMSA’s testing experts, attendee networking and other fun surprises!
Registrants will receive course training workbooks and meal gift cards (gift cards for U.S. attendees only) shipped directly to their shipping address.* Course certificates will be electronically sent upon completion of the training.
*Please ensure that your “shipping” address is where you would like your course materials and meal gift cards to be mailed. If the same as your billing address, please say “same as above” when registering. NOTE that our security measures require that your credit card billing address match your profile address.
Course A: Biocompatibility of Medical Devices – Two-Day Certification Course
Date: March 23-24, 2021
Price: $1,675 USD
The release of ISO 10993-1:2018, the release of 10993-18:2020 and the upcoming 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).
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
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Don PohlPrincipal 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, DABTToxicologist
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.