Effective CAPAs: How to Avoid Scrutiny in FDA’s Latest Area of Focus

This 60-minute CAPA training will provide participants an insight into FDA’s recent focus on effectiveness of CAPAs and how to manage your CAPA program to avoid the dreaded 483 observation.

Who will benefit:

This webinar will provide valuable assistance 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

Instructor Profile:

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.