Current Insights on the Regulatory Requirement to Validate Production and Quality System Software
AAMI is pleased to offer this 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 |
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| 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) |
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| 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
THREE WAYS TO PURCHASE
- 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 240-396-5781
- 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
QUESTIONS?
For
questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031.