QSR Class

The Essential Quality System Regulation Course
September 23, 2010
8:00 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:
Doubletree Hotel Denver North, 8773 Yates Drive, Westminster, CO 80031.  Phone:  303-427-4000
 
Faculty:

Benita Chappell, RAC, a partner in Cericon, LLC, has more than thirty years experience in leadership positions in US and worldwide FDA regulated industries that include in-vitro diagnostic products, medical devices, clinical laboratory devices, LASER products, monoclonal antibodies, biologics, and active implantable devices.  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) and Certified Auditor.

 
BE AWARE THAT THIS COURSE IS LIMITED TO 50 REGISTRANTS.
So sign up right away, if you want to attend. To register, go to www.regonline.com/QSR10
 
 
For additional details or information, contact Nan Matthews, programs@rmras.org or 303-843-6414.