Quality Assurance Management Certificate Program
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SCE Winter 2010

 BMGR654 - Quality Assurance for Medical Devices (1 class time available.)

CRNDates & TimesDay(s)CampusRoomSeatsFee
2045501/05/2010 6:00 pm-9:00 pmT Anaheim6100none

Class Begins
01/05/2010

Class Ends
03/23/2010

Course Description
This course provides students with an in-depth definition of quality assurance and its role with medical devices. The course covers the responsibilities of assurance during the manufacturing and production of a product. Topics will include management responsibilities, process controls, and other subjects providing an overall understanding of quality assurance.



 BMGR657 - Technical Writing for Bio-Medical Industries (1 class time available.)

CRNDates & TimesDay(s)CampusRoomSeatsFee
2045601/06/2010 6:00 pm-9:00 pmW Anaheim6100none

Class Begins
01/06/2010

Class Ends
03/24/2010

Course Description
This course will provide students with an overview and understanding of technical writing for the bio medical industry. The course will cover principle writing methodologies for quality assurance, engineering, manufacturing, and production of a medical device product. Topics will address documentation as related to FDA mandated requirements, ISO standards and for writing GMP procedures.



 BMGR660 - Quality Auditing for Medical Devices (1 class time available.)

CRNDates & TimesDay(s)CampusRoomSeatsFee
2045701/07/2010 6:00 pm-9:00 pmTh Anaheim6100none

Class Begins
01/07/2010

Class Ends
03/25/2010

Course Description
This course presents the principles and techniques for assessing the adequacy of a quality system for a medical device manufacturer. Coverage includes evaluating the quality system as it conforms to FDA regulatory requirements, standards, review of standard audit terms and other audit concepts.





 



Program Director | (714) 808-4575 | 1830 W. Romneya Drive Anaheim, Ca 92801 ©2010 All Rights Reserved Funded by: North Orange County Community College District School of Continuing Education Funded by: Economic and Workforce Development Program