Four 8 Hour Classes: Saturdays July 8, 15, 22 and 29 2017 (8:30 a.m - 5:00 p.m.)


International Technological University (ITU)

2711 North First St.

San Jose, CA 95134


Soly Paterson

Soly Patterson CMQ/OE
Course Coordinator 
ASQ Silicon Valley - Section 0613 
course-coordinator@asq-silicon-valley.org| 408.410.3934

Suzanne Geiss

Susie Geiss
Education Committee Chair
ASQ Silicon Valley - Section 0613 

Michele Harms

Michele Harms
Recertification Chair
ASQ Silicon Valley - Section 0613 



C105 - Certified Biomedical Auditor (CBA) 

ASQ has changed the Certified Biomedical Auditor (CBA) to a standalone certification.  CQA certification is NOT required prior to taking the CBA exam.

This course is designed for those who understand the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating, and reporting to determine quality systems adequacy.

  • You must have five years of on-the-job experience in one or more of the areas of the Certified Biomedical Auditor Body of Knowledge. 
  • At least one year must be in a decision-making role. If you have completed a degree from a college, university or technical school with accreditation accepted by ASQ, part of the five-year experience requirement will be waived.  
  • Knowledge of Statistics, Quality Management Systems are useful before taking this class.
  • Please consult the details on the ASQ website,  http://asq.org/certification/biomedical-auditor/right-for-you.html or call 800-248-1946. 

JulyInstructor George Marcel

ASQSV Official Logo

Instructor Bio

  • George J. Marcel, has over 30 years’ experience in Quality Assurance Systems in multiple industries (including medical device, biotech, automotive, commercial, green tech (wind power), and other high-tech industries) as a quality professional in roles as director, manager, engineer, supervisor, and project manager.  His past non-medical industry employers include Rockwell International, Kenetech Windpower, and Sun Microsystems.  Quality implementation focus on industry compliance, customer requirements, and quality improvement tools.
  • With over 15 years’ direct experience the medical device industry including multiple start-ups, George has hands on experience in implementing quality management systems and projects from initial development to implementing correction in commercial systems (that required revision due to non-compliance or other gaps including multiple FDA Warning letter responses).  George has worked on five PMA projects and multiple other product regulatory submissions.
  • George is a senior member of ASQ for over 25 years as well as RAPS and many other professional organizations. George has attained multiple ASQ certifications (7) including all regulated health industry focused accreditation: Certified Biomedical Auditor (CBA), Certified HACCP Auditor (CHA), and Certified Pharmaceutical GMP Professional (CPGP).    He has served as past examiner for the Malcolm Baldrige National Quality Award (MBNQA).    Education background:  Michigan State University, Oakland University, University of Michigan – Dearborn, and University of California – Berkley.


                                                     George Marcel  



Course Times

Four 8 hour Classes: Saturday, July 8, 15, 22, and 29 (8:30 a.m - 5:00 p.m.)

Lunch Time: (1:00 p.m. - 2:00 p.m.)


Course Details

Prerequisites: Please See Above!       
Hardware: A simple calculator will be sufficient to perform all calculations in the exam. Examinees may have a back-up calculator if necessary. 
Software: N/A
Required Materials: 

- Proof of online Payment 

- Pencil & Paper or laptop/tablet if you prefer

- A calculator without an alpha-numeric keyboard

- If you are an ASQ member, a current-dated ASQ Membership ID

- Valid ID(s): sites may require US citizens to provide a Driver's License or a State-Issued ID; if you are not a US citizen you must bring 2 valid forms of identification

- The Biomedical Quality Auditor Handbook available from the Quality Press, http://asq.org/quality-press/.

Learning Method: Lectures, teams, case studies, hands on approach
Class Time: 32 hours
Class Size:  25 max. participants
Facilities: Room with PC projector, whiteboard, etc.