Blog Post
Patient Safety is the Perspective for Prevention
When I first started writing this blog, the subject was remediation for regulatory inspections. But, as I progressed through the authoring of this blog, I...
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Blog Post
Remote Regulatory Assessments – Q&A: Here to Stay
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs). The FDA has...
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Blog Post
FDA Quality Management Maturity Program
Drug shortages in the pharmaceutical industry is a significant concern that has far-reaching consequences for the industry, the regulators, the healthcare system, and ultimately the...
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