Medical Device Trials 2010- What We Need to Know About Audits and Inspections
Karen Bielinski, BSN, RAC Principal Regulatory Affairs Specialist, American Medical Systems President, CARA - Consulting Thursday September 09, 2010 6:00 – 9:00 pm NEW LOCATION Concentric Medical, Inc.
301 E Evelyn Ave, Mountain View, CA 94041 Directions below Program, RAC provides global device regulatory submissions support for American Medical Systems (AMS), San Jose facility. She’s also President, CARA-Consulting, LLC providing clinical and regulatory affairs consulting services to medical device companies. Karen’s experience encompasses over 25 years in healthcare and the medical device industry. Her healthcare experience in surgical critical care and cardiac electrophysiology provide a unique perspective to her industry knowledge. Her medical device experience includes large, mid-sized and start-up companies in cardiovascular surgery, pacemakers and implantable defibrillators, left ventricular assist devices, sleep apnea, and aesthetic laser applications. She holds a BS in Nursing from Saginaw Valley State College, Michigan.
This is the year FDA is focusing on streamlining and improvements in device clinical trials. What’s new and important? What can we learn from recent device warning letters? Are you prepared for an audit or inspection? When does preparation begin and how to plan? Our speaker was invited to return this year to share her expertise after a sellout and well received presentation last year. Bring questions!
Karen Bielinski, BSN
1. Provide product examples for each medical device class 2. Identify triggers for an FDA inspection of a device trial 3. List information commonly requested during an FDA inspection of a device trial 4. List common issues in warning letters 5. Describe key elements of an audit plan
Agenda:
6:00 – 7:00 PM Registration sign-in, Networking, & Dinner Buffet 7:00 – 7:30 PM Welcome, Announcements, Board Elections, "OPEN MIC" for job referrals 7:30 – 8:45 PM Educational Program
8.45 – 9.00 PM Q&A
Target Audience:
Clinical Research Professionals
Sponsor Organizations
Study Site Investigators & Coordinators
Independent Consultants
Students of Clinical Research
Academic Medical/Clinical Researchers
Service Providers/Vendors
Institutional Review Boards
Quality Assurance
EVENT REGISTRATION before Monday, 06 Sept. 2010, 11:59PM PST Register early to assure admission; at event IF space available (+$5.00 nonmember) REGISTER? NOW – or click http://www.acrpnet.org Northern CA Chapter– or
NCC ACRP member Free
ACRP member $10.00
Non-member $15.00
