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Revisions to Q9(R1) Quality Risk Management, Getting "Recall Ready" + Warning Letter Breakdown

We look at the recent Q9(R1) Quality Risk Management revisions, highlight key takeaways from FDA's finalized recall readiness guidance, and break down a warning letter citing data integrity issues.
Newsletter #6

Welcome to Insider issue #6.

And welcome to the 110 new life science professionals who joined last month.

Today we’re looking at the Q9(R1) Quality Risk Management revisions currently open for public comment. The purpose of the guidance is to enhance the application of effective quality risk management principles by industry and regulators — and provide a systematic approach to quality risk management for improved, informed, and timely decisions.

We’re also looking at FDA’s finalized guidance on the preparations companies should take to ensure they quickly and effectively execute voluntary product recalls.

And lastly, we break down a warning letter to an Arizona drug manufacturing facility over data integrity oversights.

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The FDA Group