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Learn how RCA helped a biotech company remediate FDA 483 findings and enhance its QA system by building compliant quality…
Explore expert strategies for handling connected device recalls and crises, including response planning, communication, and compliance with regulatory expectations.
Learn how to identify and mitigate supplier quality management risks — expert strategies for supplier oversight, risk controls, audits, and…
Learn to avoid common regulatory submission pitfalls and apply best practices for successful FDA filings with expert insights on strategy,…
Learn how to address data integrity and accessibility challenges in medical devices with expert guidance on compliance, risk control, validation,…
Learn how to integrate cybersecurity into medical device software development with best practices on risk control, threat modeling, SBOMs, and…
In this article published by Pharmaceutical Technology®, Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp,…
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and…

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