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X-WR-CALNAME:B2DG- Managing complaints\,adverse events\, and recalls\,
	 Connie Hoy\, VP RA/QA\, Xoft Inc. in Sunnyvale\, CA at NOVA Room 510 
	- Eventful
BEGIN:VEVENT
DTSTART:20081007T083000
DTEND:20081007T103000
DTSTAMP:20081026T204444Z
SUMMARY:B2DG- Managing complaints\,adverse events\, and recalls\, Conn
	ie Hoy\, VP RA/QA\, Xoft Inc.
DESCRIPTION:  Bio2Device Group October 7\, 2008 Managing complaints\,a
	dverse events\, and recalls Connie Hoy Vice President of RA/QA Xoft\, 
	Inc. This presentation will review the various actions that may be tak
	en by a medical device manufacturer when it is determined that there i
	s a health risk to the public that requires action. One challenge is h
	ow to decide when a recall or correction / removal is warranted. We wi
	ll review some specific case studies that reflect the FDA perspective 
	on this. Once the decision for a recall is made\, specific documentati
	on must be generated and timelines must be met. We will then discuss w
	hat these actions are as well as how to interface with the FDA and wha
	t can be expected by the FDA. The relationship between incidents in th
	e US and outside the US will then be covered to add clarity on what is
	 appropriate. Finally\, Connie will discuss how to minimize the impact
	 of a recall on your business. Connie Hoy joined Xoft\, Inc as VP RA /
	 QA in December\, 2007. Prior to that she spent over 12 years working 
	in the medical laser industry\, most recently as VP RA/ QA at Cutera\,
	 Inc and prior to that VP RA / QA at Lumenis\, Inc. Connie began her c
	areer 22 years ago at a start-up company that developed sterile implan
	table devices. During her 8 years at Oco Biomedical\, she served as th
	e President of the Dental Implant Manufacturer's Association and the S
	outhwest Biomedical Coalition. In 1995 she joined Tissue Technologies 
	as the Director of Regulatory Affairs\, where she led the effort to be
	come one of the first ISO 9001 / EN 46001 certified medical companies 
	in the US. When Tissue Technologies was acquired by Palomar Medical\, 
	Connie served as a transition team member and subsequently worked for 
	Palomar as the team leader for ISO implementation at the Palomar home 
	office and for their subsidiaries located in Auburn\, CA and Pleasanto
	n\, CA. Connie was also an industry representative on the advisory boa
	rd that consulted with FDA on the implementation of the 1996 revision 
	of the Quality System Regulations. Connie then joined Cell Robotic\, I
	nc where she obtained the first 510(K) clearance for a medical laser d
	evice to be sold into the home. The device was used for obtaining capi
	llary blood samples for diabetes testing. This led to a move from Albu
	querque\, NM to Woodland\, CA where she continued her career in the la
	ser industry. \n
LOCATION:NOVA Room 510 @ California, United States
SEQUENCE:1225053884
UID:E0-001-014932718-8
URL:http://eventful.com/E0-001-014932718-8
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