Conference

Tuesday, June 3, 2008
9:00 A.M. - 4 P.M.

ABOUT THE INSTRUCTORS

Susan Reilly, Consultant, Reilly & Associates, LLC

Susan Reilly has over 20 years of quality assurance, quality engineering, and regulatory compliance experience in the medical device field. She is a recognized expert in the medical device industry, and is an ASQ Certified Quality Engineer, Quality Auditor, and Quality Auditor-Biomedical and an RAB QMS Provisional Auditor. Prior to becoming an independent consultant in 1999, she was Director, Quality Assurance and Compliance, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc.

Susan holds a B.S. degree in Chemical Engineering from The Pennsylvania State University. She is a senior member of the American Society for Quality and has held numerous Biomedical Division council and committee positions since 1991.

Sue Jacobs, Principal Consultant, QMS Consulting

Sue Jacobs is the Principal Consultant for QMS Consulting, Inc. a quality management consulting firm. Having been in the medical device industry for more than 19 years, she is a recognized expert in performing Quality System assessments for compliance to US FDA regulatory requirements and ISO Standards. She assists manufacturers and suppliers in developing and maintaining compliant quality system programs. Prior to forming QMS Consulting, Inc. Ms. Jacobs was a Quality System Consultant with Medical Device Consultants, Inc. (MDCI) and served as the Manager of Quality Assurance for Siemens Nuclear Medicine Group. Ms. Jacobs was the Chairman of ASQ Biomedical Division 2002-04 and is currently serving as a National Director on the ASQ Board of Directors, 2004-06. She participated at meetings of the FDA/Industry Grassroots Task Force which conceived and implemented a program to pre-announce FDA inspections, annotate FDA Form 483s, and send close-out letters after inspections.

Bruce Haggar, President, MedQ Systems

Bruce Haggar is currently President of MedQ Systems, Inc. a professional firm specializing in consulting, interim management and education services for the biomedical technology industry.

Mr. Haggar specializes in Process Validation, Design Control, Risk Management and FDA/Regulatory consulting and auditing. He is widely recognized as one of the nation's experts in process validation and medical device design control.

Mr. Haggar is a Biomedical Engineer with experience in a variety of biomedical technology firms in product development, design, manufacturing, and regulatory/quality assurance. He was a primary developer of the external automatic defibrillator technology in the late 1980's at Cardiac Resuscitator Corporation and First Medical Devices, Inc. He is active in various industry organizations including ASQ Biomedical Division where he was the Chair, AAMI, and RAPS. He also served as an Investigator for the U.S. FDA.

Michelle Johnston, Principal, Advanced Quality System Solutions

Michelle began her career in the medical device industry in 1989 with a division of C.R. Bard and from there moved into positions of progressive QA/Regulatory management responsibilities with several medical device manufacturers including Ortho Development Corporation and Genzyme Surgical Products.

From 2000-2005, Michelle was western area manager and a medical device lead auditor with British Standards Institution (BSI) Management Systems, a leading provider of quality management system registrations and assessment services. During her tenure, she conducted hundreds of quality system audits against the requirements of ISO 9001:2000, EN ISO 13485:2003, 93/42 EEC and the Canadian Medical Device Regulation. She also developed and conducted 21 CFR Part 820 internal training for medical device auditors.

Michelle joined Medical Device Consultants Inc. in 2005 as a quality systems consultant. She worked with clients to develop, implement, and improve their quality systems. She also conducted employee training, auditing, and addressed compliance issues.

She currently heads Advanced Quality Systems Solutions, a consulting company based in southern California. AQSS offers a wide range of consulting services to the medical device industry and is committed to a “hands on” practical and cost-effective approach.

Michelle holds a Bachelor of Arts degree from the University of Massachusetts. She is active in several industry organizations and has been a featured speaker on a variety of topical subjects. A native Bostonian who actually pronounces the letter “R”, she resides in the San Diego area.