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Changes to Your Quality Management System:
Planning for Unpredictable Consequences

A successful quality management system is always changing.  This is an inevitable fact of doing business in the medical device industry.  Knowing how to adjust your processes and how to adapt to these unexpected changes are key.  Any change, whether it is small, high risk, or over-arching, must be addressed to enable systemic success.  Embracing these changes with well-documented and process-oriented approaches can turn ambiguous issues into predictable outcomes.  To assist you in recognizing the many changes and finding compliant solutions, the Association for the Advancement of Medical Instrumentation (AAMI), is pleased to announce a new two-hour webinar CD, Changes to Your Quality Management System, Planning for Unpredictable Consequences. 

This program focused on the possible changes your medical device company may encounter and the ramifications that these changes can have on your quality management system.  Areas of discussion were:  design input change, supplier change, process validation change, software change, risk-related change, document change, manufacturing change, “no-change” agreements, and field change.  Speakers interactively addressed the consequences of handling these issues in a compliant and effective manner. 

How your company defines and contains change is paramount to your company’s success.  Don’t miss out on this exciting educational opportunity to learn more about maintaining control in an ever-changing regulatory and compliance environment.

SPEAKERS

  • John Gagliardi, President MidWest Process Innovation, LLC
  • Christine (Chris) Nelson, Consultant/Trainer

WEBINAR CD

Includes handout material and CD.

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

Please note: Domestic and international shipping rates apply.

THREE WAYS TO ORDER

  1. Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
  2. Fax - Select and download the order form and fax to 301-206-9789.
  3. Mail - Select and download the order form and mail with payment to:

    Changes to Quality Management System CD Package
    AAMI Publications
    PO Box 0211
    Annapolis Junction, MD 20701-0211
    Arlington, VA 22201-4795

QUESTIONS?
For questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031. For content questions, please contact Virginia Schoenauer at 703-525-4890, ext. 247.