How to Design an Effective CAPA Program, and Avoid FDA Scrutiny| June 5 – Lincoln
September 25th, 2018 // 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.
Why Attend?
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
- Compliance
- Management Representatives
- Executive Management
- Risk Management
What Is Included
With your order, we would like to offer you these items at no added cost:
- Powerpoint slides to share
- Downloadable recording
About the Instructor
About the Speaker
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years experience in U.S. FDA-regulated industries, 23 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology.  John is a graduate of UCLA.
