Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society

Events

2020

VIRTUAL EVENT

2020 Quality System Regulation Course

October 30, 2020

 

This year, due to the COVID-19 pandemic,  RMRAS is taking the QSR Class Virtual! Utilizing new technology tools for online events, the class promises to offer the same information in a new format taught by two experienced medical device industry professionals and a representative of the Denver District FDA.

 

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 basic 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 presenting this course online and streamlining the program to focus on the following aspects of the regulation – Corrective and Preventive Actions, Design Controls, Production and Process Controls, Management Controls, and Records and Document Control.

 

Go to Training has many tools which allow a virtual program to be an exciting, interactive experience that is almost live.  Chat, raise your hand, surveys, polls, tests and most importantly moving to breakout sessions. There the participants will review a case study while seeing and talking to each other.  We will use Google Chrome as the default browser to facilitate these sessions.

 

Who should attend?

This course is directed towards those who work within the design, implementation and maintenance of the quality system, QA, R&D, manufacturing, and regulatory affairs. This is an introductory course offering a high-level overview of the regulatory requirements of QSR.

 

Faculty

Ashleigh Wodushek , Principal Compliance Specialist, Medtronic  

Ashleigh Wodushek has been in the Medical Device Industry for over 10 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 took on the role of Global Process owner for Quality Governance.  She then joined GID BIO, Inc. located in Louisville, CO as the Director of Quality and recently moved to Medtronic as a Principal Compliance Specialist.

 

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 ISO 13485:2016 lead auditor certified.

 

Bryan LoveSpecial Assistant to the Program Director of the Office of Medical Device and Radiological Health Operations (OMDRHO)  

Bryan has been in this position since June 2020 and is involved with developing and implementing several Strategic Priorities for the Medical Device Program within the Office of Regulatory Affairs.  Prior to this position, he supervised a group of Medical Device Investigators for OMDRHO Division 3 since program alignment started in May 2017.  That position involved the coordination of routine and compliance inspections of medical device establishments and the completion of CDRH directed assignments within the division. 

 

His past FDA experience includes, Medical Device Specialist in 2008 for the Denver District. In 2003, he conducted inspections and investigations in the food, biologics, and medical device program areas for the Cincinnati District Office.  Bryan began his career with the FDA as a food and biologics Investigator at Baltimore District’s Roanoke Resident Post in 2002 and has achieved a Bachelor of Science in Industrial Hygiene degree from Ohio University..  

 

The registration fee t is $395.00 payable by credit card.  For companies wishing to send more than one attendee, the fee for the first person is $395.00 and $350.00/person for additional registrants.  For  information on how to receive this discount, contact Nan Matthews, programs@rmras.org or 303-843-6414. 

 

WE MUST HAVE AT LEAST 20 REGISTRATIONS IN ORDER TO HOLD THIS VIRTUAL SEMINAR.  SIGN UP AS SOON AS YOU CAN.

 

To register, go to https://cvent.me/OKErg0 

 

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

 

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Rocky Mountain Regulatory Affairs Society

 

Phone: +1 (303) .843-6414

E-mail: info@rmras.org

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