Welcome to Insider issue #29.
And a very warm welcome to the 721 new life science professionals who joined last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
In this month’s pharma section,
In our pharma section, Leonid Chagal dissects the anatomy of a robust and compliant GMP audit program, breaking down a program into planning, execution, and follow-up processes.
Our device feature, Dharmesh Patel, unpacks the first stage of the FDA’s new rule regulating laboratory-developed tests (LDTs) as medical devices, providing a playbook for compliance before the early 2025 deadline.
Finally, Jonathan Wacks analyzes the key lessons from the FDA’s recent warning letter to Brassica Pharma, which revealed critical GMP violations, including data integrity lapses and sterility issues. Learn actionable steps to ensure your operations stay compliant and mitigate potential risks in these vital areas.
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