09
May
Reflections from the PDA Pharmaceutical Manufacturing and Quality Conference 2025 - Lachman Blog

Reflections from the PDA Pharmaceutical Manufacturing and Quality Conference 2025–Singapore

We just wrapped up an engaging and insightful two days (May 6-7, 2025) at the PDA Pharmaceutical Manufacturing and Quality Conference 2025 in Singapore. As anticipated, the event delivered high-value content through impactful presentations from current and former regulators as well as seasoned industry professionals. Their thoughtful responses to audience questions added real depth to the […]

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01
May
Note pad with word what? why? who? how? when? where?

BPDRs – Is Your Team Ready to Recognize the Need for One?

Biological Product Deviation Reports (BPDRs) are coming into increasing focus during FDA inspections.  The FDA commonly requests an understanding of a site’s BPDR process and examples of BPDRs submitted to the Agency.  Furthermore, during the inspection and during evaluation of distributed licensed product, FDA investigators will evaluate “How,” “Why,” and “When” a firm determines the […]

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