Thursday, October 23, 2008
9:00 AM - 5:00 PM (Lunch 12:00 PM - 2:00 PM)
| Session 302 - Corrective and Preventive Action: a Practical Approach |
Chair: Sue Jacobs, QMS Consulting
CAPA and FDA Enforcement Trends: Tim Phillips, Compliance Officer, FDA Minneapolis District 
Data Analysis - What's Important, What's Not: Sue Jacobs
- Using the output from design controls to drive CAPA
- What data should be analyzed, how frequently, and by whom
Integrating Risk Management and CAPA: Bruce Haggar, Med-Q Systems
- When and How to Apply Risk in the CAPA Process
- Prioritization
- Risk vs. Benefit
Case Study – Using Risk Management to establish action limits for CAPA. Group discussion to follow: Faculty
CAPA – Best Practices: What's Working; What's Not: Sue Jacobs
- Procedures
- Timeliness
- Effectiveness Checks
- Resource Allocation
- Prioritization
- Automation Solution
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About the Instructors
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, Med-Q-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.
Tim Phillips, Compliance Officer, FDA Minneapolis District
Tim Philips is a Compliance Officer with the Food & Drug Administration where he coordinates legal and administrative actions against violators of the Food, Drug and Cosmetic Act. Tim has a Bachelor''s Degree in Biomedical Engineering from the University of Iowa. He joined FDA''s Minneapolis District Office in 1988. Prior to becoming a Compliance Officer, he worked for 12 years as a field investigator specializing in medical devices. Tim is a level II certified medical device investigator and a performance auditor in FDA''s medical device certification program. He is a frequent speaker at industry and FDA-sponsored medical device programs.
