November 5th, 2013 // 8:24 pm @ jmpickett
This 60 minute Webinar on CAPA training will give you insights into FDA’s new focus on CAPA effectiveness, and how to effectively manage your CAPA program to avoid an FDA warning letter or 483.
The most important area audited by the FDA is CAPA. FDA views this system as an indicator for the overall effectiveness of the firm’s Quality Management System. In recent years, CAPA has been an increasingly common finding on FDA 483 forms.
Attending this course will enable you understand FDA’s expectations regarding CAPA effectiveness, learn to demonstrate that Corrective Actions do not adversely affect the finished device quality, and provide a road-map to demonstrate that your CAPA program verifies the effectiveness of CAPA actions.
Now is the time to assess and improve your CAPA system so that you stay ahead of FDA expectations and prevent a 483 finding that could have been avoided. This webinar will present simple but powerful tools, with real world examples how companies manage CAPA systems.
Areas Covered in the Webinar:
- Understanding FDA’s increased focus on CAPA effectiveness
- CAPA fundamental principles
- How to effectively document root cause analysis
- How to demonstrate that CAPA actions have been effective
- What great Effectiveness Checks look like
- Implementing a “closed loop” CAPA system that meets company needs and regulatory requirements.
- Demonstrating that CAPA actions do not adversely affect the finished device.
- Lessons learned and after action reviews
Who will benefit:
This webinar will give important information about CAPA management to:
- Quality Assurance
- CAPA Coordinator
- Quality Control
- Supply Chain Management
- Post Market Surveillance
- Quality Systems
- Technical Management
- Operations and Engineering
- Management Representatives
- Executive Management
- Risk Management
What Is Included
With your order, we would like to offer you these six items at no added cost:
- Powerpoint slides to share
- Downloadable recording
- Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
- Article – 10 Ways to Control Compliance Costs – By John Avellanet, Cerulean Associates
- Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
- Newsletter – FDA Digest – By Expertbriefings.com. Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00
About the Instructor
Chris Cook PE, RAC, is a licensed professional engineer with over a decade of global regulatory affairs and quality experience. Mr. Cook is the Managing Director of 4Point Global Solutions, a consulting firm providing commercialization and compliance services to emerging and established medical device companies. Mr. Cook has as been responsible for regulatory affairs, quality, and compliance for multinational life-science corporations, such as Stryker Corporation, Straits Orthopaedics, and BIOTRONIK. He specializes in all areas of quality including assurance, control, and systems, Regulatory Submissions including 510(k), PMA, and MDD Technical Files, and compliance program development and management.