Day

July 1, 1999
Novartis 7/1/99 b. The annual product reviews did not include all stability results. A problem in the firm’s computer system prevented the results of stability data from printing. Additionally, the stability data from these annual reviews was used to support the Tegretol XR expiration date extension. SoftwareCPR keywords: drugs, pharmaceuticals, computer validation
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“A Software Development Process Model for Artificial Neural Networks in Critical Applications” by David M. Rodvold Colorado Technical University and Xaim Inc.presented at the International Joint Conference on Neural Networks (IJCNN’99). Washington D.C. July 1999. In this paper Mr. Rodvold addresses the challenges of using neural networks in critical applications and describes an approach to...
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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