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Having a solid understanding of the overall process and techniques used to support your organization’s corrective and preventive action (CAPA) system is important for regulatory compliance and business success.  This webinar will address the industry’s need for further education on how to identify and investigate root causes and effectively implement solutions for corrective and preventive actions.

Program content will include an overview of the current regulatory requirements and the new draft Global Harmonization Task Force (GHTF) Guidance on corrective action and preventive action and related QMS processes.  There will be a discussion on the systems your organization needs to have in place to satisfy FDA’s Quality System regulation.  The webinar will also:

• Examine the importance of trending and a risk-based escalation process
• Explore a phased approach to managing CAPA activities
• Explain how to minimize repeat investigations and increase effectiveness
• Offer industry best practices on the tools considered to be the most important by industry professionals to establish an integrated system
• Provide a forum where you can ask questions and get answers

Don’t miss out on this exciting educational opportunity to learn more about how to create a winning CAPA system!

PROGRAM OBJECTIVES

The program will illustrate straight-forward approaches to effective CAPA management and how to overcome the typical obstacles that stand in the way of an effective and efficient CAPA system.  Speakers will go beyond the regulation to educate industry on how to apply these approaches within your organization’s everyday work.  Participants will learn what tools, techniques, and methodologies are important within a CAPA system.  At the conclusion of the webinar, participants will gain an appreciation of corrective and preventive action techniques used to support a quality system and be able to utilize these tools to add value to their organization.

PROGRAM-AT-A-GLANCE

Planning Establishing sources of quality data Risk control and risk mitigation outputs Measurement and Analysis of Data Practical approach to escalating issues to CAPA Measurement and analysis of data A Phase-Based CAPA System Advantages Four phases described in the GHTF guidance Investigation Process Investigation of the reported nonconformity In-depth root cause analysis Identification of appropriate actions Verification of identified actions Implementation of actions Determining the Effectiveness of your CAPAs Eliminating recurrences and overcoming obstacles Benefits of a strong CAPA system Question & Answer Session

SPEAKERS

• Vera Buffaloe, President, Buffaloe Consulting, Inc.
• Nathan Conover, Senior Partner, PathWise, Inc.

WHO SHOULD ATTEND

The webinar is designed for quality and regulatory compliance experts, device risk managers, software developers, and validation professionals.

BENEFITS FROM PARTICIPATING IN THE WEBINAR

A live webinar is one that you can “attend” and participate in right from your office.  The savings are significant – no travel time or hassle and no travel expense.  Invite staff members to listen and participate too - all for one low fee!  It’s easy; you only need a telephone and access to the Internet.

The webinar is also interactive so you will be able to ask questions of the speakers and provide comments during the course of the program.  To submit questions prior to the webinar, please e-mail them to Virginia Schoenauer at vschoenauer@aami.org. 

MARK YOUR CALENDAR

DATE	EDT	CDT	MDT	PDT	GMT
MAR. 18, 2010	11am - 1pm	10am - 12pm	9am - 11am	8am - 10am	15:00 - 17:00

WEBINAR MATERIALS AND DIAL-IN INFORMATION

Dial-in instructions as well as the URL address for accessing the webinar and webinar materials will be e-mailed to you one week prior to the program. If you are unable to receive your materials via e-mail, please notify AAMI’s Customer Service Center upon registration and they will mail the information and materials to you.

WEBINAR FEES

Webinar — Invite your staff and co-workers to listen in for one low price!

• $315 per registrant (AAMI Member) - unlimited registrants per site
• $415 per registrant (Non-member) - unlimited registrants per site

Please note:  Your registration entitles you to one telephone connection and one computer connection at one physical location. You also have permission to make copies of the written materials for anyone else at your location who might be listening to the program with you.  Any transmission, retransmission, or republishing of the audio or web portion of this program is strictly prohibited.  International registrants may incur additional phone charges.

Webinar CD — Includes pdf of handout materials and webinar recording on CD.  Please note that the CD will be available three weeks after the program. 

• $295 for webinar registrants
• $395 for non-registrants

Please note: Domestic and international shipping rates apply.

CANCELLATION:Written requests for cancellation may be made to AAMI’s Customer Service Center until March 4, 2010.  Registrants will receive a full refund, minus a $50 cancellation fee.  No refunds will be provided after March 4, 2010.

FOUR WAYS TO REGISTER

1. Online - Click here to register online.
2. Phone - 1-800-373-3174 to order with a credit card.
3. Fax - Select and download the registration form and fax to 301-206-9789.
4. Mail - Select and download the registration form and mail with payment to:
   
   Webinar Registration
   PO Box 0211
   Annapolis Junction, MD 20701-0211
   

QUESTIONS?
For registration questions, please contact AAMI’s Customer Service Center at 1-800-373-3174. For content or format questions, please contact Jeanine Hinrichs at 703-525-4890, ext. 212.