Design Controls, an FDA perspective
Wednesday – August 10 , 2011 7:00pm to 9:00pm
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
Formal discussion will end between 8:30 - 8:45 pm to allow time for networking & updates.
Location: Triple Ring Technologies, 39655 Eureka Drive, Newark, CA 94560
Registration: ----- Special Rate----- $10 Advance Registration, $20 Walk-in
Please go to http://tinyurl.com/221729 to register. ONLY check or credit card accepted at the door.
Materials: Handouts will be provided; Please limit to immediate personal professional use only. Thank you.
Refunds: 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 is not responsible for any airfare penalties, or hotel charges that may be incurred due to sold out, cancelled, or rescheduled events.
Food: Light snacks and drinks will be provided.
Email: To be added to or removed from our email list, contact Manisha Patel, firstname.lastname@example.org
Questions: For information about this session, contact George Marcel, email@example.com