NAMSA Training Series

Check here to view the latest seminars, webinars and remote training series events.

Training Series

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.

Upcoming Event Dates:

June 3-4, Brussels, Belgium
July 8-9, Philadelphia, PA

Read More

Register Now
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.

Upcoming Event Dates:

June 5-6, Brussels, Belgium
July 10-11, Philadelphia, PA

Read More

Register Now
COURSE C: MASTERING REGULATORY STERILIZATION AND MICROBIOLOGY

Prerequisite: none

This training course discusses hot topics and regulatory expectations for a sterile single use device (SUD) and in great detail the FDA's current requirements for reprocessing of reusable devices. 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.

Upcoming Event Date:

Sept. 9-10, Austin, TX

Read More

Register Now
COURSE D: Integrating Risk Management Throughout the Product Lifecycle

Prerequisite: none
This course is geared toward those who need to have a working knowledge of design controls and risk management techniques. The objective of the course is to teach participants how to integrate risk management activities throughout the product lifecycle beginning with product development and progressing through post market surveillance to comply with ISO 14971. Design control elements that interface with the risk management process will be covered and participants will learn how and when to document various risk management activities, including Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA), Failure Modes and Effects Criticality Analysis (FMECA) and Post Market Surveillance Report. Hands-on exercises will provide an opportunity for participants to become more familiar with the structure and content of various design control deliverables and risk management.

Upcoming Event Date:

Sept. 11-12, Austin TX

Read More

Register Now

Remote Training Series

Current Regulatory Thinking in Reprocessing

by Steven Elliott
Senior Project Manager in Sterilization Validation, NAMSA

Abstract:
Reusable medical devices represent a large percentage of today’s new product development and submissions to the US FDA. Understanding and mastering the FDA Draft Guidance...

Event Date: May 21st, 2013

Read More

Register Now
Colorants: Current Thoughts and Recommendations for Biological Safety

by Don Pohl
Senior Project Manager, NAMSA

Abstract:
Medical device manufacturers are facing challenges today with 510k products, and the safe use of colorants. In this session, NAMSA focuses on how manufacturers can avoid the deficiency questions.

Date: June 18th, 2013

Read More

Register Now
Interim Analysis of Clinical Trial Data: Implementation and Practical Advice

by Chris Pulling
Vice President, NAMSA

Abstract:
Statistical methodology for conducting interim analyses of clinical trial data is well developed and accepted among the scientific and regulatory communities. As investors in medical device companies strive to reduce risk in an uncertain regulatory environment...

Date: July 23rd, 2013

Read More

Register Now

Past Events

NAMSA Remote Training Series Events will be recorded and packaged to NAMSA.com subscribers through our normal registration process. Click through on each event for more information.

RTS Archive: Aligning Global Regulatory Strategy to Decrease Time for Approval in Emerging Markets

by Seth Goldenberg, Ph.D.
Senior Principal Scientist, NAMSA

Abstract:
Emerging markets increasingly represent significant revenue opportunities for medical device companies. China has most likely passed from “emerging” status into a “must enter” status as it rapidly becomes...

Original Event Date: April 23rd, 2013

Read More

Register Now

If you would like more information on any of the seminars listed below or inquiries into future seminars and training events, please contact us.

events@namsa.com

Other Seminar Events

Biocompatibility and Performance of Medical Devices Symposium 2013

The Biocompatibility and Performance of Medical Devices Symposium is the medical device manufacturers’ leading event for science and education, specifically designed for professionals in research and development, quality assurance, regulatory affairs, product engineering and other device-related positions. You'll find expertise for every medical specialty. NAMSA is co-sponsoring the event.

Event Website

NAMSA Sponsorship Press Release

Read More

Register Now