Rocky Mountain Regulatory Affairs Society
Rocky Mountain Regulatory Affairs Society

Events

2019

2019 Quality System Regulation Course

Friday, June 21, 2019

8:00 am – 5:00 pm

 

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.

 

Cost:

Cost for the course is $395.00 including all course materials, QSR booklet, continental breakfast and lunch. 

 

Location: 

PPA Event Center, 2105 Decatur Street, Denver, CO 80211 [immediately north of Sports Authority Field]

 

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. 

 

Amanda Zorn Shu, Senior Program Manager, Senior Compliance Auditor, Philips

Amanda Zorn Shu has been in the Medical Device Industry for over 10 years.  She started as an Investigator with the Food and Drug Administration in the Chicago District and later transferred to the Denver District.  Amanda earned her Level II Investigator Certification and became the Medical Device Specialist in the Denver District.  Amanda is currently employed by Philips as the Senior Program Manager for the Level 2 Corporate Audit Team as well as a Senior Compliance Auditor; she performs international and domestic audits for facilities aligned to a variety of regulations including 21CFR, EU MDR (MDD), CMDR, ISO 13485, ISO 9001, ANVISA, TGA, Chinese NMPA and Japanese PMDA.  She has also earned her ASQ certification for Quality Auditor and is ISO 13485 and 9001 Lead Auditor Certified.

 

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.

 

To register, please go to www.regonline.com/QSR2019

 

BE AWARE THAT THIS COURSE IS LIMITED TO 40 REGISTRANTS, so sign up soon

 

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

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Rocky Mountain Regulatory Affairs Society

 

Phone: +1 (303) .843-6414

E-mail: info@rmras.org

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