COURSE C: Mastering Regulatory Sterilization and Microbiology
Newly updated for 2015, 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.
This NAMSA training is interactive, current, and useful for every attendee with job responsibilities related to the process of sterilization and assuring your sterility assurance level. Attendees will receive the most up to date information on AAMI TIR12, AAMI TIR30, AAMI/ANSI ST79, and new working groups, including Human Factors and Development of IFUs. Our team of experts presents an in depth review and analysis of newly released guidance document: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. We also discuss the obstacles of using antimicrobial agents in your medical device and standards activity pertinent to meeting FDA's expectations for antimicrobial claims. New to the 2015 agenda, NAMSA will guide you through choosing proper sterilization methods for design and materials, as well as ensuring product shelf life and proper packaging validations.
This is a course to advance the thinking and improvement of current processes within your company. Although a pre-requisite course is not required, this session is best for those with some sterilization experience. As with all sessions offered by NAMSA, we challenge you with real life case studies and experiences specific to difficult situations attendees face in daily work.
Upcoming Event Date:
- Lyon France: March 21-22, 2016
- Minneapolis, MN: June 8-9, 2016