Rocky Mountain Regulatory Affairs Society

Events

2020

2020 Quality System Regulation Course

Friday, June 19, 2020

First created by RMRAS in 1997, this is the must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

The Quality System Regulation Course is designed to provide students with a clear understanding of the requirements of this regulation as well as the deliverables that the FDA expects to find during their inspections.

This year we are streamlining the program to focus on the following aspects of the regulation – Corrective and Preventive Actions, Design Controls, Production and Process Controls, and Records and Document Control.

Who should attend?

This course is directed towards those who are responsible for the design, implementation and maintenance of the quality system; QA, R&D, manufacturing, and regulatory affairs. Management at all levels of the organization, especially those with executive responsibility, will find the legal and regulatory requirements and consequences covered in this course, enlightening.

Faculty

Ashleigh Wodushek – Director of Quality, The GID Group, Inc.

Ashleigh Wodushek has been in the Medical Device Industry for over 9 years. She started her career as an Investigator with the Food and Drug Administration in the Seattle District and later moved to the Denver District. During her time with the FDA she focused on Medical Devices and conducted inspections both domestically and internationally. Ashleigh was with the FDA about 7 years before joining Terumo BCT as a Quality System Compliance Auditor where she focused on supplier audits. She then moved into the role of Global Process owner for Quality Governance. She recently joined The GID Group, Inc. located in Louisville, CO and is the Director of Quality.

Matthew Bickford, Director of Quality System Compliance, Terumo Corporation

Matthew Bickford is a Colorado native and has a diverse background over his 19 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 ISO 13485:2016 lead auditor certified.

The cost is $395.00 payable by credit card. The registration webpage will be up in April.