February 14th, 2014

CAPA and Root Cause Analysis

Orange County Regulatory Affairs Discussion Group

Wednesday, March 5, 2014
8:00 am – 5:00 pm

DoubleTree, Irvine Spectrum
90 Pacifica, Irvine, CA 92618

Larry Bartkus, Distinguished Engineer, Quality Systems
Edwards Lifesciences

Blake Bevill, Director of Compliance Branch
U.S. Food and Drug Administration (FDA) Los Angeles District Office

James (Rusty) Lusk, Principal
Quality Systems International
Program Managers:
Paul Kramsky, President, Rockin’ Regulatory, Inc.
Janet Rubin-Halpert, RAC, Sr. Regulatory Affairs Specialist
Corrective and preventive action (CAPA) is a vital quality management systems process, critical to a company’s ability to identify, address and prevent recurrence of product or process problems. CAPA consistently remains one of the most frequently cited areas of noncompliance in FDA inspections and warning letters.

This program will provide the nut-and-bolts for implementing and managing an effective CAPA program and will feature experts from both industry and FDA who will share their experience and perspectives on what constitutes a well-oiled CAPA program — including failure investigation and root cause analysis — and the pitfalls that manufacturers should avoid to avert an FDA 483 citation or warning letter.

This program will also include a case study which will provide attendees the opportunity to participate in the evaluation and resolution of a CAPA problem, and will conclude with a panel discussion.


7:45 – 8:15 am
Registration and Continental Breakfast

8:15 – 8:20 am

8:20 – 9:20 am
CAPA is not a Noun: Understanding the Key Elements of CAPA; CAPA Definitions and Triggers; Implementing and Managing an Effective CAPA Program; Preventive Action Overview; Overview of CAPA Effectiveness Monitoring
James (Rusty) Lusk, Principal, Quality Systems International
9:20 – 10:45 am
Conducting Effective Root Failure Investigations and Root Cause Analysis; Tools to Implement Optimal Corrective Action among Possible Corrective Actions; Corrective Action Documentation
Speaker TBD
10:45 – 11:00 am
11:00 – 11:45 am
Typical Problems FDA Observes: Manufacturer Pitfalls with CAPA and How to Address Them
Blake Bevill, Director of Compliance Branch, U.S. Food and Drug Administration (FDA) Los Angeles District Office
11:45 am – 12:30 pm
12:30 – 1:15 pm
Corrective Action Optimization and Effectiveness Monitoring (e.g., scope, data, duration, sampling)
Larry Bartkus, Distinguished Engineer, Quality Systems, Edwards Lifesciences

1:15 – 1:45 pm
Presentation of CAPA Case Study
1:45 – 3:05 pm
Attendee breakouts to work on case study
3:05 – 3:20 pm

3:20 – 3:45 pm
Presentation of case study results

3:45 – 4:15 pm
Preventive Action — Details

4:15 – 5:00 pm
Panel Discussion with all Speakers

OCRA Members: $200
Non Members: $250
Students/Government: $100

Registration fee includes continental breakfast, lunch, parking and access to electronic presentations (if approved by speakers for distribution).

For more information, view this flyer.