Sheraton Boston Hotel 39 Dalton Street Boston, MA 02199 SAFETY SPECIALIST October 1& 2 COURSE A: BIOCOMPATIBILITY OF MEDICAL DEVICES- TWO DAY CERTIFICATION COURSE October 3 & 4: COURSE B: CONTINUING EDUCATION FOR THE BIOLOGICAL BOSTON October 2018 INFORMATION: Registration fees include: Certificates of completion for participants NAMSA is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs NAMSA has agreed to follow RAPS established operational and educational criteria Opportunity to interact with instructors, all of whom are experts in the medical device industry Lunch and beverages Lodging: We have provided hotel information for your convenience. Attendee is responsible for all travel arrangements including reservations for lodging. If you would like to reserve a room at the discounted rate of $269 per night, single occupancy, please use the following website: https://www.starwoodmeeting.com/Book/ NAMSA0918 . REGISTRATION PRICES: Course A: Biocompatibility of Medical Devices—Two Day Certification Course Prerequisite: None Dates: October 1 & 2, 2018 Course B: Continuing Education for the Biological Safety Specialist Prerequisite: Course A: Biocompatibility of Medical Devices Dates: January 31 & February 1, 2018 Register for two courses and save! Single Course pricing: $1525 regular $1275 Early registration pricing ends August 20, 2018 Two Courses pricing: $2600 regular $2090 Early registration pricing ends August 20, 2018 EDUCATIONAL CREDITS: Course A: Biocompatibility of Medical Devices: Two Day Certification Course, and Course B: Regulatory Toxicology of Medical Devices—An Advanced Course have been pre-approved by RAPS as eligible for up to 12 credits each towards a participant’s RAC recertification upon full completion. FOR MORE INFORMATION: https://www.namsa.com/resources/education/training NAMSA proudly offers educational and customized training events throughout the year. If you would like more information about the training courses in Boston or how we design training programs for our clients, contact Sheri Krajewski-Bibins at phone: 404.428.8989 or email: [email protected]Training Series
Transcript
Sheraton Boston Hotel 39 Dalton Street Boston, MA 02199
SAFETY SPECIALIST
October 1& 2 COURSE A: BIOCOMPATIBILITY OF MEDICAL DEVICES- TWO DAY CERTIFICATION COURSE
October 3 & 4: COURSE B: CONTINUING EDUCATION FOR THE BIOLOGICAL
BOSTONOctober 2018
INFORMATION:
Registration fees include:
Certificates of completion for participantsNAMSA is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs NAMSA has agreed to follow RAPS established operational and educational criteria Opportunity to interact with instructors, all of whom are experts in the medical device industryLunch and beverages
Lodging:
We have provided hotel information for your convenience. Attendee is responsible for all travel arrangements including reservations for lodging. If you would like to reserve a room at the discounted rate of $269 per night, single occupancy, please use the following website: https://www.starwoodmeeting.com/Book/NAMSA0918 .
REGISTRATION PRICES:
Course A: Biocompatibility of Medical Devices—Two Day Certification CoursePrerequisite: NoneDates: October 1 & 2, 2018
Course B: Continuing Education for the Biological Safety SpecialistPrerequisite: Course A: Biocompatibility of Medical Devices Dates: January 31 & February 1, 2018
Register for two courses and save!
Single Course pricing: $1525 regular$1275 Early registration pricing ends August 20, 2018
Two Courses pricing: $2600 regular$2090 Early registration pricing ends August 20, 2018
EDUCATIONAL CREDITS:
Course A: Biocompatibility of Medical Devices: Two Day Certification Course, and Course B: Regulatory Toxicology of Medical Devices—An Advanced Course have been pre-approved by RAPS as eligible for up to 12 credits each towards a participant’s RAC recertification upon full completion.
FOR MORE INFORMATION:
https://www.namsa.com/resources/education/training NAMSA proudly offers educational and customized training events throughout the year. If you would like more information about the training courses in Boston or how we design training programs for our clients, contact Sheri Krajewski-Bibins at phone: 404.428.8989 or email: [email protected]
Training Series
2018 NAMSA Training Series—Boston, MA
COURSE A: BIOCOMPATIBILITY OF MEDICAL DEVICES—TWO DAY CERTIFICATION COURSEPrerequisite: none
This course is geared toward those who need to have a working knowledge of biocompatibility. The objective of the course is to teach participants how to use standards to establish a biological safety evaluation plan. Participants also learn how to document and implement their plan. Use of risk assessment is covered and participants will practice evaluating biological risk. Both days are structured to be hands-on. Participants must attend and complete all exercises to be certified as a biological safety specialist.
Course Objectives • Understand and apply ISO 10993-1 and the FDA Guidance on its use. Know how to use the ISO documents to locate information that
you need.• How to apply Materials characterization, and more importantly learn how to use the information to understand biological safety.• ISO 14971 and how to use it. Learn how to use ISO 10993-1 as a tool for hazard identification.• Learn the difference between evaluation and testing. Recognize when testing is absolutely necessary and how to avoid unnecessary
testing.• Understand what tests to select and how to choose among various options. Answer the question: When is testing not the only option?• Learn how to develop a program that guides your device on the regulatory path and reduces your time to market.• Gain knowledge on the principles of toxicology, FDA consensus standards, and Good Laboratory Practices.• Practice how to execute your plan from development to completion and how to schedule and document the implementation of your
biocompatibility plan.• Understand where the FDA and other regulatory bodies differ and how to navigate the challenges.
• Gain a deeper understanding of global regulatory expectations for biological safety.• Know how to review reports for accurate data and work with a laboratory when unexpected results are reported.• Understand evaluating complexities for drug/device combination devices.• Familiarization with calculating allowable limits for cancer, chemical mixtures, and assessment of unidentified chemicals.• Experience working application with two, real life exercises to calculate allowable limits, experience testing errors and how to mitigate
them, and then manage a device from concept to market clearance.
Course Date October 1&2, 2018
COURSE B: CONTINUING EDUCATION FOR THE BIOLOGICAL SAFETY SPECIALISTPrerequisite: Course A: Biocompatibility of Medical Devices—Two Day Certification CourseNewly updated for 2017, this 2-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 the Table 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 with actively calculate safe limits with practical chemical characterization data.
Additionally in the hands-on workshops, 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. Participants will walk away with the knowledge of how to plan and a strategy to endure potential obstacles.
Course Objectives:
LocationSheraton Boston 39 Dalton Street Boston, MA 02199
• Regulatory Affairs and Quality Assurance Professionals• Design and Manufacturing Engineers• Product Managers• Laboratory Managers, Sterilization Specialists and Microbiologists• Process Development and System Engineers• Biological Safety Analysts• Anyone interested in learning more about meeting the test requirements of
regulatory bodies in world markets• Those who need continuing education for RAPS Certification
Course Date
October 3&4, 2018
Who Should Attend?
LocationSheraton Boston 39 Dalton Street Boston, MA 02199
