QSR Class
The next class is not yet scheduled. The information below is for the most recently conducted class. Let us know if interested for scheduling of the next class.
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The Essential Quality System Regulation Course
Date: October 14, 2009
Hours: 7:30 am – 5:00 pm
A newly designed, 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.
Location:
PPA Event Center, 2105 Decatur Street, Denver, CO 80211. Phone: 303-433-8247.
Faculty
With Cericon, Benita has helped companies successfully clear Warning Letters and Consent Decrees of permanent injunction. In addition, Benita develops and teaches Food and Drug Law courses on a national level.
Benita has a Bachelors degree in Chemistry and masters-level course work in healthcare law. Certifications include Regulatory Affairs Certified (RAC), Certified Auditor.
John Chappell, RAC, a partner in Cericon, LLC, has over thirty years of experience in leading and improving quality systems primarily for medical device manufacturing companies worldwide.
He has fulfilled a broad range of positions within medical device companies prior to consulting including the functions of Quality, Regulatory, Engineering and Operations, and titles that range from the shop floor to Worldwide VP. Successes include building self-sustaining quality and regulatory systems; successful remediation of FDA Warning Letters and an FDA consent decree.
John has a Bachelor's degree in Mathematics and a Master's degree in business administration. Certifications include Regulatory Affairs Certified (RAC-US, EU).
To register, go to www.regonline.com/QSR09
For additional details or information, contact Nan Matthews, rmras@themattgrp.com or 303-843-6414.