Program now available on CD!

AAMI is pleased to offer a new two-hour webinar CD on the Current Insights on the Regulatory Requirement to Validate Production and Quality System Software.  Program content focuses on how to use current guidance, standards, and enforcement information to achieve software compliance in an efficient and defensible manner.  The speakers also discuss and provide updates on key concepts from a number of current documents and working groups.

This program is essential for quality assurance and regulatory affairs personnel, manufacturing and operations managers, compliance managers, software product/process development personnel, and consultants. 

Don’t miss out on your opportunity to learn about the latest software guidances and initiatives from the FDA and industry!

PROGRAM-AT-A-GLANCE

	FDA’s Computerized Systems Used in Clinical Investigations
		Relevancy of guidance document to various types of production and quality system software
		Relationship between guidance document and FDA Part 11
		- Interpretation and enforcement
		Use of guidance document for efficient validation and Part 11 compliance
	AAMI’s Technical Information Report (TIR) on Validating Production and Quality System Software
		History of the TIR
		Why FDA participated in the TIR development
		“Critical Thinking” and its relationship to efficient validation
		“Compliance Science”
		TIR status
		Tools in the toolbox
		- Good Automation Manufacturing Practice (GAMP) - Institute of Electrical and Electronics Engineers (IEEE)
	FDA Update
		Internal FDA software compliance regulator training
		Revision to Part 11

SPEAKERS

• Alan Kusinitz, Managing Partner, SoftwareCPR
• John F. Murray, Jr., Software Expert, Office of Compliance, Center for Devices and Radiological Health, U.S. Food and Drug Administration

WEBINAR CD

• Includes handout material and CD. 
• $295 for webinar registrants / $395 for non-registrants
  
  Please note: Domestic and international shipping rates apply. The CD will be available three weeks after the program.

THREE WAYS TO PURCHASE

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:
   
   Software Compliance Webinar 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.

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