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Event NameIntroduction and Review of Quality System Regulations for the Medical Device Industry (Basic GMP and ISO-Medical Devices):
Event Date(s) Tuesday, May 21, 2013  to Wednesday, May 22, 2013
Event Location Ohlone College Newark Center campus, Room 1102, 39399 Cherry Street
Newark, California
Cost$100 registration fee
DescriptionTime: 8:30 am to 4:30 pm

A two-day workshop that provides an introduction to, or a review of, the two most important quality system regulations that govern medical device design and manufacturing: the "Good Manufacturing" (GMP) regulation required by the US FDA (21CFR820) and the "ISO 13485:2003" standard required by the European Commission. Those two documents apply to start-ups as well as established companies if they wish to market products in the USA or Europe, respectively. The format of the workshop is the reading of the regulation/standard, word by word (they are not long), combined with explanations of the meaning of the text, as well as discussion of illustrative examples of the wrong and right ways to implement them. The examples will be provided by the instructor and any students who would like to contribute. Students will conduct real-life situation evaluations. The workshop does not require prior regulatory training. This workshop provides 1.4 recertification units for those seeking or renewing ASQ CQA, CBA or CQM or similar certifications.

SponsorNorthern California Bay Area Biotechnology Center (NCBC)
Host CompanyOhlone College
Contact Information Phone: 510-979-7952
Fax:   510-659-6446 
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