NAMSA seminars are designed to help regulatory affairs experts, quality assurance professionals, and R&D and process-development engineers establish a comprehensive, organized program to meet product safety and regulatory compliance standards.
Our seminars provide the most current information on nonclinical safety testing required by regulatory bodies for market approval of medical devices.
Upcoming Seminars
COURSE A: Biocompatibility of Medical Devices: Two Day Certification, COURSE B: Regulatory Toxicology Of Medical Devices: An Advanced Course, and COURSE C: Traditional and Novel Sterilization Methods
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.
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.
COURSE CTraditional 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.
9/14/2010 - 9/17/2010
Minneapolis, MN
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COURSE A: Biocompatibility of Medical Devices: Two Day Certification Course COURSE C: Traditional and Novel Sterilization Methods of Medical Devices - Singapore
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.
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.
10/18/2010 - 10/22/2010
Singapore,
Learn more and register
