A Commentary on the Draft EMA Annex 15 Changes in the Context of The CAI OR Program
Why the EMA Annex 15 Concept Paper Signals a Shift—and How It Aligns with The CAI Six Pillars of Operational Readiness In Feb 2026 the EMA with...
Read MoreFrom Compliance Burden to Strategic Capability
As global regulations continue to evolve, life sciences organizations face increasing pressure to meet stringent compliance expectations without slowing innovation or compromising product quality. The...
Read MorePatient 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...
Read MoreRemote 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On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).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...
Read MoreFDA 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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