Conference
Wednesday, June 4, 2008
9:00 A.M. - 4 P.M.
| Session 302 - Corrective and Preventive Action: A Practical Approach |
Chair: Sue Jacobs, Principal Consultant, QMS Consulting
Welcome: Sue Jacobs, Principal Consultant, QMS Consulting
CAPA and FDA Enforcement Trends: Sue Jacobs, Principal Consultant, QMS Consulting and Faculty
Data Analysis - What’s Important, What’s Not: Sue Jacobs, Principal Consultant, QMS Consulting
- Using the output from design controls to drive CAPA
- Data analysis - outside the formal CAPA process
- What data should be analyzed, how frequently and by whom
Integrating Risk Management and CAPA: Bruce Haggar, President, Med-Q Systems
- When to Apply Risk in the CAPA Process
- Prioritization
- Resource Allocation
- Risk/Benefit
Case Study – Using Risk Management to establish action limits for CAPA.
Ground discussion will follow: Faculty
Investigating the Problem: Susan Reilly, Consultant, Reilly & Associates, LLC
- Data collection for investigation
- Tips on avoiding “scope creep”
- Contributing cause vs. root cause
- Documenting the investigation
- Monitoring the investigation process
CAPA – Best Practices, What’s Working, What’s Not: Sue Jacobs, Principal Consultant, QMS Consulting
- Procedures, Timeliness, Effectiveness Checks,
Resource Allocation Prioritizations, Automation Solution
Q&A: Faculty |
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.
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.
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