FDLI’s 2026 annual conference covered several industry hot topics, with a particular focus on AI and how the FDA is leveraging technology and existing resources to improve efficiency and engage with industry. Although progress appears to be on the horizon, industry should remain mindful of the FDA’s current structural limitations and the ongoing need for […]
The FDA’s April 2, 2026 Warning Letter to a cosmetics company marks a defining moment for the regulated industry, not because artificial intelligence (AI) was used in this firm’s operations, but because it was deployed without effective governance within a Pharmaceutical Quality System (PQS). In this case, management relied on AI agents to draft GMP-critical regulatory […]
There’s always a certain energy at PDA Week – the kind that comes from a shared sense that our industry is moving, sometimes faster than we expect. This year in Denver, that energy felt different. More focused. More urgent. And in many ways, more practical. As both an exhibitor and attendee representing Lachman Consultants, I […]
Register Now: Advancing AI Adoption in Manufacturing Under the Existing FDA & EMA Frameworks Date: March 11, 2026 Time: 10-11am ET Registration link: https://comms.arnoldporter.com/64/6809/landing-pages/accept–blank-.asp?sid=600d0e23-07f6-4967-9925-756d145366f1 Artificial intelligence is quickly becoming a powerful tool across pharmaceutical and biotechnology manufacturing. Yet many organizations remain uncertain about how to adopt AI within regulated environments, particularly in the absence of […]
If GMP already accommodates AI, the next challenge is practical execution. The goal is not to “add AI compliance,” but to embed AI into existing quality systems with intent and discipline. Part 2 of this series (here) unconsciously introduced the often-misunderstood concept of “critical thinking,” which is easy to say, but difficult to perform in […]
The prevailing industry narrative around artificial intelligence (AI) governance often presumes that we are entering fundamentally uncharted regulatory territory—territory that will necessitate entirely new compliance architectures. The recent FDA–EMA guidance “Guiding Principles of Good AI Practice” suggests otherwise. It reinforces a more pragmatic conclusion: the existing global GMP framework already provides the structural foundation necessary for […]
Overview of Regulatory Alignment The recent joint FDA–EMA guidance “Guiding Principles of Good AI Practice in Drug Development” has sparked conversation across the industry. Do you view it as a major shift or dismiss it as “just another guidance”? The truth usually sits between those extremes. This blog series will examine the signals, which we […]
The concepts of Speak Up and Quality Culture have received renewed attention with recent developments of the European Union’s Artificial Intelligence Act. Lachman recently blogged about the importance of a healthy quality culture (Speak Up! Does Your Quality Culture Have a Voice?), and new proposals under the Digital Omnibus package in the EU introduce three […]
Pharmaceutical Technology has featured Charlie Gibbons, Director of Compliance at Lachman Consultants in an article, AI and Digital Oversight in Pharma Supply Chains: PDA Regulatory Conference Insights, following his recent presentation at the PDA Global Regulatory Conference. In his session at the conference, Charlie provided valuable insights into today’s evolving regulatory landscape, highlighting the practical […]
The AI Action Plan was initiated by Executive Order (EO) 14179, signed in January 2025, which directed the federal government to remove barriers to AI innovation and develop a national strategy. Following a public consultation that generated over 10,000 comments, the plan was released in July 2025 with input from industry, academia, and government stakeholders. […]
