Software used to design, develop, manufacture, or otherwise control the quality of medical devices must be validated for its intended use by 21 CFR, Part 820 (FDA’s Quality System regulation). This regulation covers a very broad scope of software, ranging from simple spreadsheets and database reports to enterprise-wide IT solutions for CAPA and complaint handling. Based on AAMI TIR36:2007 Validation of software for regulated processes, this new AAMI webinar bridged the gap between the regulation and industry best practices. Program speakers will provide a high level introduction to the content and structure of the TIR, presented some of the validation philosophies that are the foundation for the methods discussed in the TIR, and discussed the practical application of the TIR to common validation challenges and compliance issues.
PROGRAM OBJECTIVES
The webinar challenged the way medical device manufacturers think about validating regulated process software. Methods suggested in AAMI TIR36 discourage a checklist approach that is overly prescriptive. Instead, the TIR recommends an approach that emphasizes “critical thinking” and empowers those validating software to take innovative approaches to building confidence in the software for its intended use. The speakers walked-though AAMI TIR36, introduced new validation concepts, and provided practical information on using the TIR to solve daily validation needs in a more value-added way.
PROGRAM-AT-A-GLANCE
| The Primer | ||
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Where we are | |
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Where we would like to be | |
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How to get there | |
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Critical thinking | |
| Regulatory Context | ||
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Automated Processes 21 CFR 820.70(i) | |
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Quality System Regulation 21 CFR 820 | |
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Electronic Records 21 CFR 11 | |
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The general principles of Software Regulation | |
| Software Intended Use | ||
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Software Purpose and Intent | |
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Software Use Requirements | |
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Software Requirements | |
| Brief Overview of the Organization and Content of the TIR | ||
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Understanding the Process Being Automated | |
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The Role of Risk Analysis and Management | |
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The "Max and Min" Models of Validation | |
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The Validation "Toolbox" | |
| Discussion of Examples from the TIR | ||
SPEAKERS
- John Murray, Software Compliance Expert, Office of Compliance, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Member of AAMI TIR36:2007 workgroup
- David Vogel, President, Intertech Engineering Associates, Inc., Member of AAMI TIR36:2007 workgroup
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
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 301-206-9789.
- Mail - Select and download the order form and mail with payment to:
TIR36 Webinar CD Packet
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.