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September 14 & 15, 2010 8:00am-5:00pm
***FULL: COURSE A: Biocompatibility of Medical Devices: Two Day Certification Course
Prerequisite: 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.
Program Topics
· Understand ISO 10993-1 and the FDA G-95 memorandum. Know how to use the ISO documents to locate information that you need.
· Comprehend materials characterization, but more importantly learn how to use the information to understand biological safety.
· Comprehend ISO 14971 and how to use it. Learn how to use ISO 10993-1 as a tool for hazard identification.
· Distinguish the difference between evaluation and testing. Recognize when testing is absolutely necessary.
· Determine what tests to select and how to choose among various options. Understand when testing is not the only option.
· Learn how to develop a program that guides your device on the regulatory path and reduces your time to market. Topics addressed include principles of toxicology, FDA consensus standards, and Good Laboratory Practices.
· Understand 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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September 16 & 17, 2010 8:00am-5:00pm
COURSE B: Regulatory Toxicology of Medical Devices: An Advanced Course
Prerequisite: Biocompatibility of Medical Devices: Two Day Certification Course
This 2-day training course is designed for those who have received certification in the NAMSA Advisory Services Biocompatibility of Medical Devices Two Day Certification Course. The objective of this course is to teach beyond the basics of Tables A and B in ISO 10993. In addition to traditional medical devices, we will address combination products and biologics. Participants will not only learn how to assess their device for biological risks but also understand when testing is necessary. They will discover where to find information and how to incorporate it into their assessments. Calculating safe limits will also be discussed. Hands-on workshops will provide an opportunity to work with case studies on real medical devices which will provide 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.
Program Topics
· ISO 10993-1:2009 states, "The role of this part of ISO 10093 is to serve as a framework in which to plan a biological evaluation…" This course teaches you how to use the standard as a framework.
· How to review scientific literature and evaluate clinical experience
· How to evaluate a device like FDA
· How to identify gaps in data based on your own risk analysis
· How to evaluate relevant data from all sources
· How to use the general principles of ISO 10993-1
· How to use the new standard even if FDA doesn't recognize it.
· How to use Figure 1 in ISO 10993-1:2009
· Review dose dependent vs. dose independent responses
· Reviewing the "new" ISO requirements
· Biodegradation
· Toxicokinetic studies
· Immunotoxicology
· Looking at combination products and biologics.
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September 16 & 17, 2010 8:00am-5:00pm
COURSE C: Traditional and Novel Sterilization Methods of Medical Devices
Prerequisite: none
This training course discusses regulatory expectations for a sterile single use device (SUD), reusable devices, non-sterile SUDs, reprocessed SUDs and devices processed aseptically. By discussing ways of meeting regulatory expectations, and the key issues reviewers are looking for, this course will help you accelerate your product to market.
We will examine the use of a validation master plan as well as preparing for various studies that are required to fulfill the plan. Radiation, moist heat and ethylene oxide sterilization methods will be discussed as well as packaging.
Program Topics
Phase 1: Design
· The Effects of Sterilization Methods on Plastics & Elastomers
· Choosing Radiation Sterilization – An Introduction
· Choosing EO Sterilization – An Introduction
· Choosing Alternative Methods
Phase 2: Validation
· The Requirements for Radiation Validation (ISO 11137-1)
· The Requirements for Ethylene Oxide Validation (ISO 11135)
· Ethylene Oxide PPQ
· Ethylene Oxide MPQ
· EO Residuals
· Parametric Release
· Maintenance of Validation for Radiation and EO Sterilization
· Product Adoption for Radiation and EO Sterilization
Phase 3: Post-Validation
· Bacterial Endotoxin Testing
· Sterilization Final Exercise
Who Should Attend?
- Regulatory Affairs and Quality Assurance Professionals
- Research, Design and Manufacturing Engineers
- Product Managers
- Laboratory Managers
- 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
- Sterility Assurance Managers
If you have additional questions:
Contact Anne Alfaro Urfer at 419.662.4498 or email events@namsa.com.
