Leverage New Tools for
Device CAPA Compliance
Your office, Dec. 19, 2013
Agenda
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:
Dan O'Leary, President, Ombu Enterprises |
11:15 a.m. – 11:30 a.m. |
Break |
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:
Jason Spiegler, Director, Strategic Market Development, Camstar Systems; Chair, ASQ Charlotte, NC Section |
12:30 p.m. – 1:30 p.m. |
Lunch |
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:
Greg Meyer RAC, CQA, President and Principal Consultant and Trainer at Compliance Media Inc. |
2:30 p.m. – 2:45 p.m. |
Break |
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:
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 |