Risk Evaluation in Biopharmaceutical Technology Transfer: Why a Risk-Based Approach Is Essential for GMP Success. Successful biopharmaceutical technology transfer depends on more than process knowledge.
Drafting Perfect 483 Responses: The New FDA Guidelines Explained. FDA Form 483 observations are issued when investigators identify conditions that may violate cGMP requirements.
Beyond Documentation: Solving the Tacit Knowledge Gap in Pharmaceutical Tech Transfer: This article discuss why Your Documentation Is Not Enough and How to Institutionalize Expert Know-How. Visit us for more…
Navigating the Pitfalls of MSAT for Successful Technology Transfer: In the biopharmaceutical sector, MS&T responsibilities extend to both upstream and downstream processes. This includes optimizing cell culture conditions, managing bioreactor performance, and ensuring effective purification
FDA regulation of Artificial Intelligence (AI) and Machine Learning (ML) follows a risk-based framework focused on safety and effectiveness throughout the product lifecycle. As of mid-2025, the FDA has authorized over 1,250 AI-enabled medical devices, with nearly 80% used in radiology .
