The basic principle of corrective and preventive action requires that we define appropriate controls for measurement and analysis to identify nonconformities and potential nonconformities. Learn why the CAPA acronym is misunderstood and how it contributes to an ineffective process for corrective action. The 4 phases of corrective and preventive action as described in the GHTF SG3 proposed Guidance Quality management system − Medical Devices − Guidance on corrective action and preventive action and related QMS processes will be presented and discussed. A networking session is planned to apply the principals learned. We welcome your active participation in this session.

Monday, June 7, 2010
Session 101: Corrective Action and Preventive Action − A Practical Approach Focus on the process, not the acronym

Chairs: Sue Jacobs, Principal Consultant, QMS Consulting, past chair of ASQ Biomedical Division; and Steven Walfish, President, Statistical Outsourcing Services, past chair of ASQ Biomedical Division

Overview GHTF SG3 Guidance Document "Guidance on corrective action and preventive action and related QMS processes": FDA CDRH speaker invited

Measurement and Analysis − Deciding what data is relevant?: Sue Jacobs, Principal Consultant, QMS Consulting, past chair of ASQ Biomedical Division; and Steven Walfish, President, Statistical Outsourcing Services, past chair of ASQ Biomedical Division

Improvement Phase: Initiating Corrective Action: Brenda Tregellas, Director, WW Compliance, Quality Systems & Customer Quality, Diabetes Care Services Group, Johnson & Johnson

Management Input: Paul Carlson, Program Manager Global CAPA Certification, Abbott Laboratories

Best Practices & Lessons Learned − Networking Session