Rocky Mountain Regulatory Affairs Society (RMRAS)

A one-day course covering the fundamentals of the Quality System Regulation.  This is a must-attend course for all personnel working in quality systems or regulatory affairs in the medical device industry.

 

The Essential 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. Practical solutions as well as consequences of non-compliance will also be covered.

 

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 $275.00 including all course materials, QSR booklet, continental breakfast and lunch.    Payment is available by credit card or check.  To register, go to www.regonline.com/QSR07

 

Location: 

PPA Event Center, 2105 Decatur Street, Denver, CO 80211.  Phone: 303-433-8247.

 

Faculty:

Benita Bradford-Chappell, CERICON LLC

Benita has over twenty-five years of experience in regulatory affairs, regulatory compliance, and quality systems development primarily in the medical devices, LASER-containing medical devices, in vitro diagnostics, biological products, and blood. Throughout her career, Ms. Chappell has worked closely with the Food and Drug Administration, both at the local levels and at the national level and developed strong credibility with Agency personnel.  She is a speaker at numerous conferences on regulatory affairs, regulatory compliance, and quality systems development, and teaches Food and Drug Law courses at a national level.  . 

 

Lynette Makowski, Regulatory Affairs Manager, Gambro BCT

Lynette is responsible for the management of the Quality System Program at BCT.  She oversees the Internal Audit Program and is lead in external regulatory audits including customer audits. Gambro BCT manufactures three main device types for blood processing equipment and tubing sets with a variety of configurations.  Each main device consists of cross-functional operating teams responsible for CAPA.

 

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