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 discussions.
One standout session came from Lachman’s Andy Hopkins, who provided a detailed and practical perspective on the importance of a robust Contamination Control Strategy (CCS). His insights on integrating the CCS into the overall quality management system underscored its value as more than just a regulatory requirement; it is a strategic tool for ongoing quality assurance.
We’re grateful to the PDA, conference organizers, speakers, and participants for hosting an event that continues to push our industry toward scientifically sound, evidence-based, and continuously improving practices.
Having had a moment to reflect, I’m struck by the consistent themes woven throughout the conference—from the evolving role of AI in regulatory practices to innovations in modalities and technologies, operational excellence in manufacturing, and foundational microbiology principles tied to Annex 1. These themes aren’t just timely, they’re essential as our industry continues to evolve in response to global patient needs and regulatory expectations.
I left the conference feeling reenergized and better equipped to face today’s quality and manufacturing challenges with renewed purpose. On the heels of change come opportunities to raise the bar in compliance, quality, and innovation.
At Lachman, we believe in staying ahead of change. As highlighted in one of our recent posts (here), the FDA has begun conducting an increased number of unannounced inspections overseas—yet another sign of the shifting regulatory landscape. Our team of former regulators and industry veterans is ready to help you navigate these developments with confidence.
As your organization grows and evolves, know that Lachman is here to partner with you. We’re ready to support your team in meeting the next set of challenges—and the opportunities they bring. Reach out to us today at LCS@LachmanConsultants.com.
