Rocky Mountain Regulatory Affairs Society is pleased to announce a new focus on the fundamental building blocks of all 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 four quality/regulatory professionals including an FDA investigator (invited). The fundamentals to be emphasized are:

• Corrective and Preventive Actions (CAPA)
• Management Controls
• Design Controls
• Production and Process Controls

The new focus is intended to stimulate class interaction and sharing of real-world experience.

Who Should Attend
This course is directed towards those who work within the design, implementation and maintenance of a quality system and work in QA, R&D, manufacturing, and/or regulatory affairs. This is an introductory course offering a high-level overview of the fundamental requirements of all Quality Systems

SPEAKERS

Matthew Bickford, Director of Quality System Compliance, Terumo Corporation

Matthew Bickford is a Colorado native and has a diverse background over his +20 years within the pharmaceutical and medical device industries.  After graduating with a degree in Molecular, Cellular, and Developmental Biology and Biochemistry, Matthew’s career began in pharmaceutical manufacturing and product development.  He then moved into biotech as a validation professional and then entered the medical device industry where he is currently the Director of Quality System Compliance within the Terumo Corporation.  Matthew also has a master’s degree in Engineering Management and is a Certified Medical Device Auditor from ASQ.

Bryant Hart, Senior Quality Consultant, ERI Group

Mr. Hart has 30+ years of technical experience including Quality System Management, Regulatory Affairs, Project Management, Design Control, Labeling, UDI, Risk Management, Manufacturing, Nonconforming Materials, CAPA, Auditing, Testing, Integration and Customer Support in the Medical Device and Industrial sectors.  Mr. Hart is experienced in managing product safety, performance and EMC testing, technical file maintenance, post-market surveillance, internal and supplier auditing, FDA inspections, ISO audits, Design Control, management reviews and QMS training.  A hands-on contributor, Mr. Hart has authored, implemented and maintained medical device Quality Management Systems necessary for US, EU, Canada and international compliance.

John Mann, Director, ERI Group

Mr. Mann has established himself as a leader in the overall integration and execution of regulatory affairs & quality system planning and execution into the medical device design, development, and manufacturing continuum.  During his over 25 years in the medical device field, he has successfully implemented regulatory approvals for medical devices in both the US, EU and other global markets.  He has successfully mitigated and remediated recall and market withdrawal situations for large and small companies, and he has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU and global market requirements.  Mr. Mann is adept at the implementation of and compliance with the FDA Quality System Regulation (QSR), ISO13485, ISO14971, ISO10993, 60601-1, IEC62304, ISO14155 and a broad range of other technology and device specific standards.  Mr. Mann is widely recognized for presentations and leadership in his field.

James Montero, Consumer Safety Officer, Division 3
Office of Medical Device and Radiological Health Operations, FDA

Mr. Montero received his bachelor of science degree in biology from Brigham Young University in 2008.  In 2009 I started as a Consumer Safety Officer with the FDA.  He has been conducting medical device inspections throughout the western states and internationally since 2010, inspecting everything from wound dressing and anti-snoring mouthpieces to fluoroscopic x-ray machines and transcatheter heart valve replacement systems.

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

For companies wanting to send more than two people, the third and/or additional  registrations are priced at $395.00, more than a 10% reduction.  Check with Nan Matthews for details on how to receive the discounted rate.

A course syllabus in PDF format is available on the RMRAS website.

To register, go to https://cvent.me/la9dA1

For questions or additional information, contact Nan Matthews, programs@rmras.org