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Biomed/Biotech SIG: FDA's Case for Quality and Product Metrics - Medical Device Perspective

Where
Kelly's Deli Conference Center
Next to the entrance to 7519 Standish Drive
FDA/CVM Center
Rockville, Maryland 20855

When
Dec 15, 2016 6:00 pm - 8:45 pm (GMT -5:00) EST

�FDA�s Case for Quality and Product Quality Metrics
� Medical Device Perspective�

To be presented by

William C. MacFarland, MS, MBA, PE
CQE, CBA, CSQE, CSSBB, CMQ/OE, CRE
Director, Division of Manufacturing and Quality
Office of Compliance
Center for Devices and Radiological Health, US FDA

Thursday, December 15, 2016

6:00 � 6:20 PM � Networking; Pizza/drink
6:20 � 8:45 PM � Program
8:45 � 8:55 PM � Door-prizes drawing; Networking

Online Registration site: https://asq509.org/ht/d/DoSurvey/i/35817

Open to Public �
$5: non-ASQ members to cover pizza/drink cost;
Free: ASQ members, veterans, senior citizens, past speakers, US PHS Commissioned Corp officers, teachers, students, interns, residents, postdocs, FDA Commissioner�s Fellows, MJ-DC members, NTUAADC members, CAPA members, NTMUADC members, CKUAADC members, NTHUAADC members, NJTUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, NCARSQA members, OCA-DC members, AAMB members, ACAP members, DC Leaders Club members, BioTrain volunteers, and current job-seekers

Location: Kelly�s Deli Conference Center, 7529 Standish Place, Rockville (Derwood, for GPS users), MD 20855

Registration Deadline: Please register by Thursday noon, December 15, 2016.

Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; [email protected] or 240-793-8425 (cell).

Driving directions: By Cars: From I-270 (N or S bound): Take Exit 9A and exit from the FIRST right exit; turn left (east) onto Shady Grove Dr.; turn right (south) onto Rockville Pike (Route 355); turn left (east) onto East Gude Dr.; turn left (north) immediately onto Crabb�s Branch Dr.; turn left (west) immediately onto Standish Place. The first building on your right side is 7519 Standish Place; open parking). The venue is on the first floor of 7529 Building with its external entrance opposite to the left side of 7519 building main entrance. By Metro trains: Off from Red Line Shady Grove Station, and take RideOn Route 59 TOWARD ROCKVILLE and get off from �Calhoun Place� stop. Standish Place is next to the Bus stop. Our venue is within 2 min of walking distance from the stop.

Summary:

Mr. Bill MacFarland will provide an update on FDA�s Case for Quality, a joint effort among FDA, the device industry, and the Medical Device Innovation Consortium (MDIC), to put more emphasis on medical device quality beyond a state of mere regulatory compliance. In February 2013, Bill presented to the ASQ Biomed SIG on early steps that the agency was taking.

Mr. MacFarland will update us on their progress, including introduction of a maturity model, analytics, and metrics. Towards the end of Bill�s presentation, in addition to taking general questions, he plans to lead an open discussion on best practices for developing product quality metrics.

Speaker�s Bio:

Mr. William C. MacFarland is the Director, Division of Manufacturing and Quality, within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. This division�s work relates to ensuring the safety and effectiveness of medical devices through its promotion of current approaches to quality assurance and quality systems as they relate to device design and manufacturing.

Mr. MacFarland has previously served in multiple management positions in CDRH as well as held positions in the device and regulatory consulting industry. He received an MBA from the University of Maryland, an MS in Biomedical Engineering from Case Western Reserve University, and his BS degree in Electrical Engineering from Clarkson University. Currently he maintains a Professional Engineers license in Maryland and is an ASQ Certified Quality Engineer, Certified Biomedical Auditor, Certified Software Quality Engineer, Certified Six Sigma Black Belt, Certified Manager of Quality/Organizational Excellence, and Certified Reliability Engineer.

This event is cosponsored by NTU Alumni Association DC Chapter (www.ntuaadc.org) and Chinese American Professional Association DC Chapter (www.capadc.org).