Yearly Archives: 2020

This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International Organization for Standardization (ISO) standards development teams. Participants will learn how to develop and maintain a quality system program that [...]

This one-day virtual event will encompass topics regarding advances in connectivity, automation, and security within the operational context of hybrid manufacturing applications across multiple vertical industries. To register and for more info:  https://isaautomation.isa.org/2020-iiot-smart-manufacturing-conference/

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors [...]

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors [...]

Explore the critical, dynamic world of automation cybersecurity with ISA’s expert contributors. Learn about threats, emerging protection methods, best practices, fundamentals of the ISA/IEC 62443 series of standards, and implementation tips to bring a standards-based approach into your facility. For more info:  https://isaautomation.isa.org/virtual-events-program-cybersecurity/

Join us for an Education & Workforce update explaining policies that will impact businesses and how the Pandemic is changing our Workforce. We will hear from TN Department of Education, Commissioner Penny Schwinn and TN Department of Labor & Workforce Development, Commissioner Jeff McCord. Learn about K-12 and what the future may look like along with [...]

For the thousands of people diagnosed every year with life-threatening blood cancers like leukemia and lymphoma, a cure exists. Over the past 30 years Be The Match ® , operated by the National Marrow Donor Program ®  (NMDP), has managed the largest and most diverse marrow registry in the world.  They work every day to save lives [...]

Learn how to develop and maintain a quality system program that conforms with the FDA’s Quality System Regulation (21 CFR 820) and the international quality management standard, ANSI/AAMI/ISO 13485:2016. For more info:  https://www.aami.org/training/quality-systems

The U.S. Food and Drug Administration has issued emergency use authorizations for select sterilization systems that will allow N95 or N95-equivalent respirators to be decontaminated. The sterilization systems will help address the shortage of these vital masks used by healthcare workers to protect themselves from exposure to the novel coronavirus.   This May 4 webinar [...]

Governor Lee issued Executive Order 29 on Friday, to allow restaurants to reopen at limited capacity. The order created questions as some local governments considered issuing their own reopening plans and what that would mean in conjunction with Governor's Lee Tennessee Pledge. Today, Attorney General Herbert Slatery issued a legal opinion on Governor Lee's executive [...]