NCDG Third 2011 Quarterly FDA Community Forum

ASQ-Biomedical Division

NCDG Third 2011 Quarterly FDA Community Forum


Triple Ring Technologies 39655 Eureka Drive Newark, CA 94560	Wednesday, Aug. 10, 2011 7:00 PM - 9:00 PM

Details

Event Description:
Our 3rd quarterly discussion of 2011 with the FDA is your opportunity to hear directly from the local FDA.

This event will focus on “Design Controls, an FDA perspective” beginning with the familiar design control waterfall diagram as the basis, with discussions on each step, and tying the QSR into design control application.

The FDA investigator’s perspective as to how investigators look at the your medical device company’s design controls inspection will be covered. Proactively, a discussion will focus on making sure your company’s design control efforts are addressing your product design issues long before the FDA ever sees the design history files.

Moderator:    George Marcel, Quality Assurance Manager , ArKal Medical

Featured FDA Speaker:    Eric W. Anderson, Supervisory Consumer Safety Officer
US FDA San Francisco District

Eric W. Anderson is a Supervisory Consumer Safety Officer in FDA's San Francisco District. He supervises FDA Consumer Safety Officers (CSOs) who perform inspections and investigations of regulated companies, including medical device companies. He is the primary supervisor in the district for medical device activities, including pre-market inspections, and monitors these programs for the district.

Prior to becoming a supervisor in April 2004 Mr. Anderson worked as a CSO (also known as an investigator) in both Los Angeles District and San Francisco District for fourteen years, performing inspections and investigations of many FDA-regulated companies and institutions in the fields of food manufacturing, drug residues in cattle, blood banking, and medical devices. Between 1994 and 2004 he specialized in medical devices, becoming certified in medical device inspections at Level II in 1999. During that same time he conducted numerous inspections of foreign medical device manufacturers in both Europe and Asia.

Mr. Anderson holds a Bachelors of Arts in Physical Sciences from the University of California at Berkeley
Materials: Handouts will be provided; Please limit to immediate personal professional use only. Thank you.

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ASQ-Biomedical Division Purchase/refund policy: The default refund policy is to provide full refunds up to 14 days before the event, and future credits after that time. Individual events may have different refund policies, and these will be noted on the registration page. Normally, the $15-$25 discussion group meetings are non-refundable. ASQ Biomedical Division reserves the right to cancel, reschedule any event, or to change speakers. Please be advised that ASQ Biomedical Division or ASQ Headquarters is not responsible for any airfare penalties, or hotel charges that may be incurred due to sold out, cancelled, or rescheduled events.

Acteva's Purchase/refund policy: Refunds and cancellations are provided only at the discretion of the organization hosting or sponsoring this event. Acteva issues credits only when directed to do so by the sponsoring organization. Contact refunds@acteva.com or the sponsoring organization for further details.

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