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Biological Safety Training—San Diego

About

Date/Time

Date(s) - February 28, 2022 - March 3, 2022 All Day

Location

Andaz San Diego
600 F Street
San Diego, CA 92101

*** In-person training ***

COVID-19 Safety Precautions
The safety and wellness of our Clients, staff and speakers are of the highest priority and our commitment to you is to facilitate a safe, comfortable learning environment for our upcoming event.

  • Masks will be required for all attendees and will be worn by all venue staff.
    • Masks will not be required during breakfast, lunch or when eating during breaks.
    • Speakers, when presenting, will not be required to wear masks.
  • Attendees will be seated at tables with a social distance of three (3) feet.
  • Breakfasts, lunch buffets and snacks will be served by venue staff only.

Should you have any additional questions, please contact Shauna Brick, Global Marketing Event Manager, at sbrick@namsa.com or (763) 213-7571.

 

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

Date: February 28 – March 1, 2022
Location: Andaz San Diego
Price: $1,675 USD (early registration discount of $1,400 USD ends Friday, December 31, 2021)

The release of ISO 10993-1:2018, 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, as well as how to 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 and recognize when testing is absolutely necessary or avoidable
    • 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! – SOLD OUT

February 28 – March 3, 2022 $2,860 USD (early registration discount of $2,300 USD ends Friday, December 31, 2021)

NOTE: Our security measures require that your credit card billing address match your profile address.

 

Course B: Continuing Education for the Biological Safety Specialist

Prerequisite: Course A: Biocompatibility of Medical Devices – Two-Day Certification
Date: March 2-3, 2022
Location: Andaz San Diego
Price: $1,675 USD (early registration discount of $1,400 USD ends Friday, December 31, 2021)

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.

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! – SOLD OUT

February 28 – March 3, 2022 $2,860 USD (early registration discount of $2,300 USD ends Friday, December 31, 2021)

 

NOTE: Our security measures require that your credit card billing address match your profile address.

*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com

 

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Biological Safety Training—San Diego

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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

Principal 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.