When do you initiate a CAPA?
How do you review triggers and determine trends?
What constitutes good documentation?
How to do a root cause analysis?
Risk management integrated into CAPA?
How to write a good effectiveness check?
Review and approval cycles?
Cross site review?
Training requirements and training programs?
Preventive versus Corrective actions
The presentation will walk though the creation of a CAPA and highlight some of the common pitfalls and how to avoid them! It will discuss some key good documentation practices based upon practical experience in a large medical device company

Learning Objectives:

• CAPA from A to Z and its common pitfalls.
• What are some of the common questions asked by auditors?
• The advantages and challenges of a global system and areas of caution when going electronic.

Discussion Leader: Bernadette Low

Bernadette has been with Abbott (formerly Guidant) for over 16 years initially at a pilot facility in the UK and latterly at the Temecula, CA plant. She has held a variety of management positions, including Complaint Handling, Regulatory Affairs, Supplier Development and Quality Systems Improvement. Most recently she led a cross divisional team introducing a new CAPA process and electronic tracking system across Abbott Vascular. This was successfully rolled out to multiple sites in 2007. She is currently responsible for the CAPA department-monitoring CAPA timeliness, trends and assisting owners with their investigations-and a Quality Systems Group working on aligning to one Quality system across the division.
Prior to joining Abbott, she worked for the Department of Health in the UK as a technical expert. She audited medical device manufacturers all over the world for compliance to UK requirements, with particular emphasis on sterilization and hygiene.
Bernadette has a Bachelors degree in Microbiology and is RAC certified both for EU and US.

The roundtable Discussion will utilize the synergy of our well-served Subject matter expert with your Regional Industry Peers. Please submit discussion questions on-line and help make this a valuable experience for everyone.


For more information, contact: Event Coordinator; Marina Guevrekian at (626) 303-7902 ext. 2381 or e-mail mguevrekian@staar.com

Note: As volunteers in a not-for-profit professional organization ASQ Biomedical, SCDG (Southern California Discussion Group) is committed to providing low cost high value events for biomedical professionals and the local community. We are able to keep our costs low by utilizing a registration system that incurs minimal administrative overhead expenses and minimizes excess time and effort spent by our volunteers to bring you these events. Please help us continue providing low cost quality programs to you by using the system that works well for us. If you do not wish to use the registration system to preregister, you may attempt to register at the event, however seating is limited therefore entrance and/or food can not be guaranteed. Also, due to the nature of the low pricing scheme and the registration system used, we are unable to perform refunds.
Note: Please do not respond to Kimberly Syre directly as she is simply performing an email service on behalf of ASQ. She is not involved with the specific event described above. Any questions can best be answered by the contact person identified above.
Compliance with the Can-Spam Act of 2003: This email is being sent in the course of normal Division business to the email address of record. We are not responsible for forwarded emails. If you no longer wish to receive email communications from Southern California Discussion Group of the Biomedical Division, please unsubscribe.

Food: Boxed Dinner Provided. Sandwiches, Fruit, Chips, Cookies, and Beverage
Please specify sandwich type when registering

Note: We have recently changed registration services to Turnstiles for our discussion group events. This will require you to set up an account the first time you register for an event. It is quick and will expedite future registrations.

To encourage interaction, seating is limited to the first 40 registrants, so sign up soon!

To Register :	http://asqbiomed.turnstilesystems.com/ProgramDetail.aspx/TheAZofCAPAandcommonpitfallstoavoid Members $20.00, Non Members $30.00 (.3 R.U.s awarded)
Meeting Date :	August 20, 2008
Time:	5:30pm to 8:30pm
Meeting Location:	Biosense Webster 15715 Arrow Highway, Irwindale, CA 91706
Food:	Sandwich (turkey/beef/vegie), chips, and beverages provided.
Contact for questions:	Event Coordinator; Marina Guevrekian at (626) 303-7902 ext. 2381 or e-mail mguevrekian@staar.com
Notification:	To change your ASQ email preferences for event notification: Visit http://www.asq.org Click on the "ASQ Membership Sign-in" button and login using your member number and password. Then click on the "My Account" button and choose the "Change work/home addresses and e-mail" option to update your information and preferences. Note: It may take ASQ up to three months to finalize actions with respect to changes made.

** If you wish to OPT-OUT of receiving future ASQ 702 Meeting invitations, or update your contact info, you will need to log-in at ASQ and change your E-mail preferences here: http://www.asq.org/members/account/manage-account.html

** If you no longer wish to receive email communications from Southern California Discussion Group of the Biomedical Division, please unsubscribe.