When

Friday, March 10, 2017 from 8:00 AM to 5:00 PM PST
Add to Calendar 

Where

International Technological University

2711 N 1st St

San Jose, CA 95134

 

Contacts


Azadeh Adibi
Education Coordinator 
ASQ Silicon Valley - Section 0613 
course-coordinator@asq-silicon-valley.org 408.806.2305

Suzanne Geiss

Susie Geiss
Education Committee Chair
ASQ Silicon Valley - Section 0613 
asqedu@gmail.com / 831.239.2016

 

B105 - Internal Audits 

Overview
This class teaches management audit skills that will help you gain "buy in" for a more effective corporate audit function.
  • Departmental auditing (company wide)
  • Corrective and Preventive Action
  • Supplier audits
  • Auditing requirements from domestic (FDA) and international regulatory perspectives
  • Preparing for an external regulatory audit from both domestic and international auditors
  • Audit checklists for all quality system areas
  • Basic understanding of the Quality System Regulation and International Quality Management Systems
----------------------------------------------------------------------------------------------------------------------

Instructor Barry Craner

Barry Craner

 

Instructor Bio

  • Barry Craner is retired from industry (formerly Vice President QA/RA, Stellartech Research Corporation), but continues to lecture and consult.
  • Education/Certifications: Barry holds two masters degrees, four certifications from ASQ, is RAC (RAPS), and served on the White-House Council on Y2K (Medical Devices). 
  • Management Fields: During his 40 year career in domestic and international management of engineers and scientists he has engaged in various senior, principal and management roles in engineering, quality assurance, in several firms in the medical device, aerospace and Information Technology arenas. 
  • Auditing: He has performed many 1st, 2nd and third party audits of medical device firms and suppliers. 
  • Professional Activities: He has been active in the ASQ Biomedical Division for 30 years, having served three times as Chair of the Northern California Biomedical Discussion Group, as Past Chair of the ASQ Biomedical Division, and of the San Diego Section of ASQ. 
  • Teaching: Currently teaches for the Silicon Valley Section, three classes in medical device quality assurance technologies: Risk Management, Design Control, and Auditing. As a Professor, Barry continues to teach a graduate semester class since 2007 in Risk Management in the Masters in Quality Assurance Program at the California State University, Dominguez Hills.  And, Since 2009, he has been an Instructor at the University of California Santa Cruz Extension, teaching Risk Management in certification programs in Medical Devices and Regulatory Affairs.
  • Honors: Barry is a Fellow of the American Society for Quality, was honored in 2008 by ASQLA with the Simon Collier Quality Award, in early 2010 with the ASQ Marvin Rosenbaum Distinguished Service Award, and in November that year, with the Stanley Marash Scholarship to speak at the International Quality Congress in Tel Aviv, Israel.  In 2015, Barry was honored by the ASQ Biomedical Division naming a scholarship (Barrett C. Craner Scholarship) for Quality Assurance professionals desiring to follow advanced academic pursuits in the QA field.

 

 

--------------------------------------------------------------------------------------------------

Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.

--------------------------------------------------------------------------------------------------

Course Details

Prerequisites: None                  
Hardware: N/A   |  Software: N/A                              
Required Materials: 

- Proof of online Payment 

- Pencil & Paper or laptop/tablet if you prefer

- 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

Learning Method: Lectures, teams, case studies, hands on approach
Class Time: 8 hours
Class Size:  25 max. participants
Facilities: Room with PC projector, whiteboard, etc.
--------------------------------------------------------------------------------------------------