MDTIOC.ORG - New Certificate Program

Certificate Programs: Workshops

Course Schedule

To register for any of the following courses:

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If you are a returning student, click here.

BMGR630 - Quality System: ISO 13485:2003 Basics (1 class time available.)

CRN	Dates & Times	Day(s)	Campus	Room	Seats	Fee
30574	06/07/2010 MWF 5:30 pm-9:30 pm 06/11/2010 MWF 5:30 pm-9:30 pm	MWF MWF	Anaheim	TBA	9	none
Click here for more information about this course (CRN 30574). Class Begins 06/07/2010 Class Ends 06/11/2010 Course Description This course provides an overview of the quality management system requirements for manufacturers of medical devices defined by the ISO 13485:2003 standard. It is designed for all employees involved in developing, implementing and maintaining a quality management system, including managers, supervisors, and staff, including new hires and incumbent workers.

BMGR635 - Overview of FDA's Medical Device Regulation (1 class time available.)

CRN	Dates & Times	Day(s)	Campus	Room	Seats	Fee
30572	05/17/2010 MWF 5:30 pm-9:30 pm 05/21/2010 MWF 5:30 pm-9:30 pm	MWF MWF	Anaheim	TBA	5	none
Click here for more information about this course (CRN 30572). Class Begins 05/17/2010 Class Ends 05/21/2010 Course Description Course provides an overview of the U.S. Food & Drug Administration (FDA) regulation pertaining to medical devices. Topics include FDA regulatory requirements and quality system regulation; pre-market notification and approval process; complaint handling and reporting; and U.S. labeling regulations.

BMGR640 - Fundamentals of GMP and QSR (1 class time available.)

CRN	Dates & Times	Day(s)	Campus	Room	Seats	Fee
30573	05/03/2010 MTh 5:30 pm-9:30 pm 05/10/2010 MTh 5:30 pm-9:30 pm	MTh MTh	Anaheim	TBA	8	none
Click here for more information about this course (CRN 30573). Class Begins 05/03/2010 Class Ends 05/10/2010 Course Description Course covers the fundamentals of Good Manufacturing Practice (GMP) and Quality System Regulation (QSR). Topics include Food and Drug Administration (FDA) regulations in relation to quality systems and controls; employee safety in the design and construction of facilities; equipment and maintenance issues; and protection of products against contamination.