Rocky Mountain Regulatory Affairs Society

Events

Rocky Mountain Regulatory Affairs Society
presents
Quality Systems: Focus on Fundamentals (ISO and FDA)
Wednesday, September 24, 2025
College Hill Library
Front Range Community College, Westminster, Colorado

RMRAS is pleased to announce a new focus on the fundamental building blocks of quality systems in its course “Quality Systems: Focus on Fundamentals.” Taking recommendations from past attendees and instructors, this streamlined one-day program will be taught by two quality/regulatory professionals providing real-word experience. This is an introductory course offering a high-level overview of the fundamental requirements of a Quality System.

High-level Topics to Be Covered:
* QMS Overview and Regulatory Framework
* Management Controls
* Design Controls and Risk Management
* Corrective and Preventive Actions (CAPA)
* Production and Process Controls Including Supplier/External Controls
* Industry Future Outlook

Lunch will also be provided with an opportunity to network and jump into some Q&A with the presenters and industry experts.

Who Should Attend:

This course is directed towards those who work within
* Design/R&D
* Sales/Marketing
* Quality System Owners
* Manufacturing
* Quality Assurance / Regulatory Affairs
* Anyone wanting to learn more about Quality System structure and regulation

SPEAKERS

Brandyn Abbott, Chief Quality Officer, OnemataDC

Brandyn Abbott’s experience in the Life Science industry has focused on all aspects of Quality and Operational excellence for the past fifteen years. Currently, Brandyn is the Chief Quality Officer at OnemataDC. OnemataDC is a Quality and Regulatory consulting organization supporting pre and post market efforts for Medical Devices, Tissue, HCT/Ps, and Combination Product companies globally. As head of Quality Brandyn develops, drives and delivers strategies to support quality and operational efficiency for both OnemataDC and their clients.

Bryant Hart, Co-Owner, InterPointe Consulting
Bryant Hart has over 30 years of experience in the Industrial, Manufacturing, Testing and Medical Device sectors. Bryant's background includes being the Management Representative for Medical Device manufacturers in the US, UK and EU and a hand's-on manager of QMS activities such as Design Control, Labeling, UDI, Risk Management, Manufacturing, Nonconforming Materials, CAPA, Auditing, Testing and Customer Support. Bryant is the co-owner of InterPointe Consulting, Quality and Regulatory consulting with an emphasis on supporting QMS needs of startup and small Medical Device manufacturers.

REGISTRATION FEE

The cost is $450/person payable by credit card including morning refreshments, lunch and course material.

For companies wanting to send more than two people, the third and/or additional registrations are priced at $395.00/person. Details on how to receive this discount are described on the registration webpage under Fees

To register, go to https://cvent.me/azrwyy

For questions or additional information, contact Nan Matthews,303-843-6414 or programs@rmras.org