Tuesday, May 21, 2019

7:30am – Registration; 8-9:30am – Program

NITA Training Center

1685 38th Street

Suite 200

Boulder, Colorado 80301

Program Summary

Corrective and Preventive Actions (CAPA) are cornerstones of the Quality System for modern medical device and pharmaceutical companies. The FDA’s Quality
System Inspection Techniques Manual for example has CAPA as the starting point for onsite inspectors that will determine the other areas they will audit. During this presentation, Steve Beauchamp – Quality Director at Eversana – will describe the regulatory background for CAPA, how to meet inspector’s expectations, and how to structure a CAPA system that will work for your company without becoming a resource sink and an audit trap.

Key Takeaways

Attendees will learn about the background and application of a Corrective and Preventive Action system as an integral part of their overall Quality System, as well as how to integrate CAPA activities into their organization to address product and process issues to ensure safe, effective, and commercially successful products.

Presenter Bios

Steve Beauchamp, BSME, MBA

Steve is currently a Quality Director at Eversana in Wheatridge, CO providing consulting and contract work to medical device and pharmaceutical companies and has over 30 years’ experience in establishing and running Quality Systems for medical device companies. He has worked with large companies such as Johnson and Johnson and Medtronic as well as medium and smaller sized organizations including start-ups. This background and experience allows him to tailor new or existing Quality systems and their components into compliant entities that are adapted to the company’s needs and size.