Virtual Conference

Leverage New Tools for
Device CAPA Compliance

Your office, Dec. 19, 2013



10:00 a.m. – 10:15 a.m.

Welcome and Introduction

10:15 a.m. – 11:15 a.m.

Data Analysis Techniques You Need to Survive — Device Compliance Guru Reveals What Makes the Difference

CAPA is complex. One of the least understood and frequently cited portions is the analysis of processes, records, and other sources of quality data. In this roll up your sleeves session, industry expert Dan O’Leary pops the hood and shows you how the analysis engine should run. You’ll learn how to create a data analysis program that works, bolstered by a solid understanding of data sources, their interrelationships, and the appropriate statistical methodology to analyze them.

Attendees will learn how to:

  • Create procedures to drive effective CAPA compliance
  • Analyze processes, work operations, concessions to assure that are integrated into and support CAPA programs
  • Develop strong procedures for quality audit reports, quality records, service records, complaints
  • Employ required statistical methodology — a key focus of FDA’s recent inspections

Dan O'Leary, President, Ombu Enterprises

11:15 a.m. – 11:30 a.m.


11:30 a.m. – 12:30 a.m.

Cut the CAPA: the Bottom-Line Value of Prevention — Understanding the Role Prevention-oriented CAPA Strategies Can Play in Increased Efficiency and Profitability

An effective CAPA program can improve the bottom line. In this session, long-time industry analyst Jason Spiegler uses case studies and specific scenarios to demonstrate how a preventative approach to CAPA has saved time and money for regulated entities – and how it can do the same for you.

Attendees will learn:

  • The benefits of a preventative CAPA program
  • What are the smart investments to make?
  • Case studies: The benefits of preventive programs
  • How to leverage CAPA beyond compliance

Jason Spiegler, Director, Strategic Market Development, Camstar Systems; Chair, ASQ Charlotte, NC Section

12:30 p.m. – 1:30 p.m.


1:30 p.m. – 2:30 p.m.

CAPA Systems, Failure Investigations and Trending: A Review of First Principles

Statistical process control relies on a valid number of data points to determine significance. When doing error analysis under GMPs, one is expected to determine the extent of damage caused by an out of spec situation and perform corrective action to address the root cause of the problem. Greg Meyer will discuss how to behave ethically and scientifically when analyzing a limited number of data points.

Greg Meyer will:

  • Distinguish core principles in CAPA, statistical analysis and statistical process control which come into play when performing investigations
  • Discuss an ethical framework which calls upon sound historical and practical precedents to help determine when statistical tools are appropriate when making quality decisions

Greg Meyer RAC, CQA, President and Principal Consultant and Trainer at Compliance Media Inc.

2:30 p.m. – 2:45 p.m.


2:45 p.m. – 3:45 p.m.

Here Comes the FDA Investigator —You Can Read the QSIT Manual All You Want, But What Are Investigators Really Looking For?

You’ve learned from the best practices, and worst mistakes, of other companies’ programs. You’ve developed what you believe to be a robust CAPA program. Guess what? It won’t matter much if you can’t demonstrate it to an FDA inspector. In this session, Ken Miles brings his more than 28-year inspection experience at FDA to give you valuable insights into the mind of an FDA inspector.

Attendees will learn:

  • What any FDA investigator — young, old, newbie or veteran — are thinking when they walk into your plant
  • How to anticipate any potential red flags that can send an inspection south – fast.
  • How to work with an FDA inspector before, during and after the inspection.
  • How other companies’ bad CAPA compliance programs can be a learning tool

Ken Miles, Principal, Alpha Quality Assurance; formerly a senior FDA medical device investigator for 28 years

3:45 p.m. – 4:00 p.m.

Closing Comments and Adjournment