Guest Speaker: Will McQuillan, Cordis
This webinar will explore the owner's and management's perspectives regarding roles and responsibilities, and present best practice for organizational engagement to ensure a successful CAPA program. From the owner's perspective we will focus on how to identify the required resources to investigate, and manage a CAPA by understanding how to communicate findings, expected timelines, and what resources are availalble internally and externally to facilitate compliant and timely CAPA completion. From CAPA managers perspective the focus will be on how to support the user population and to effectively ensure compliant and timely CAPA files. There will be an emphasis on CAPA status communication and isssue escalation that is designed to disseminate key information to management for more challenging resolutions and potential scope/timeline changes.
During this webinar, Mr. McQuillan will address:
- File management
- Roles and responsibilities
- Issue identification
- Scoping and containment
- Risk evaluation, investigation and approval
- Implementation
- Linkage verification
- Effectiveness monitoring
At the conclusion of the presentation you will understand:
- CAPA file Management in a CAPA system, including clearly identifying roles and responsibilities for successful closure
- Risk evaluation and mitigation
- Defensible investigation and implementation documentation
- Quality system closed loop linkage
- Effectiveness monitoring and information dissemination for closure
Your Speaker: Mr. McQuillan has previously worked for LifeScan, a Johnson & Johnson Company. His experience includes working in CAPA, Product QA and Complaint Investigation departments at both LifeScan and Cordis. Having worked as a Worldwide CAPA manager, McQuillan has successfully deployed global CAPA solutions, improved cycle time and effectiveness of CAPAs in multiple operational companies, and developed international partnerships for the sustained success of a CAPA program. He has conducted training related to understanding CAPA, GMP practical applications, root cause investigation and the nonconformance process. He has been involved in multiple FDA inspections, including staging room management, front room auditee and subject matter expert preparation.