Date/TimeDate(s) - June 28, 2022 - June 29, 2022 All Day
Registration is now closed
*** VIRTUAL TRAINING ***
Join NAMSA for our highly requested virtual Continuing Education for the Biological Safety Specialist Training on June 28-29, 2022 (8:30am-4:30pm Central Daylight Time U.S./3:30pm-11:30am 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 B: CONTINUING EDUCATION FOR THE BIOLOGICAL SAFETY SPECIALIST
Date: June 28-29, 2022
Price: $1,850 USD
Prerequitsite: Biocompatibility of Medical Devices – Two-Day Certification Course
This two-day training course is designed for those who have received certification to 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 also 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.
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
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, DABTPrincipal 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.