April 8, 2024
Quality culture, a term that has been gaining traction in regulatory compliance, is taking center stage in the life sciences industry. In a recent webinar below, industry experts discussed the FDA’s growing interest in quality culture (QC) and its pivotal role in ensuring the success and safety of pharmaceutical and medical device products. Before diving […]
April 1, 2024
In today’s pharmaceutical manufacturing landscape, trust is paramount. Patients rely on drug manufacturers’ integrity to provide safe and effective medications to manage complex, targeted health conditions. However, in a recent case, a company had been manufacturing and distributing adulterated drugs, putting lives at risk, for nearly a decade. Recent revelations highlight an infrequent but nevertheless […]
March 25, 2024
New requirements for cosmetic product manufacturers under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) are being phased in throughout 2024, affecting cosmetics products and facilities. That means cosmetics manufacturers must analyze their quality systems to identify gaps and ensure they are ready to implement any necessary changes to comply with the new law. […]
March 11, 2024
In the realm of regulatory compliance, one acronym consistently looms large: CAPA or Corrective and Preventive Action. It resonates with anyone involved in FDA-regulated industries, and no matter how diverse my consulting work may be, CAPA always finds its way back into the spotlight. While I’m passionate about helping companies enhance their process control, integrate […]
March 4, 2024
In the dynamic landscape of biopharmaceuticals, ensuring the potency of cellular therapy or gene therapy (CGT) products is a paramount objective. This draft guidance serves as a compass, delineating recommendations for establishing a robust and science-driven strategy aimed squarely at potency assurance strategies. By meticulously addressing manufacturing intricacies, process control, material management, and rigorous testing […]
February 26, 2024
The FDA and other global regulators rely on data reviews during inspections to determine whether a pharmaceutical or medical device manufacturer operates within regulatory requirements and expectations. The credibility of that data is a crucial parameter in the regulator’s assessment of whether operations are compliant—or not. Data integrity refers to the credibility—reliability, validity, authenticity, and trustworthiness—of various data presented for regulatory review. Questions […]
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