Implementation of AI solutions is evolving quickly from experimentation to operational deployment within the life sciences industry. Currently, AI-powered tools are deployed for pharmacovigilance ...

An FDA inspection letter goes hand in hand with running a business that produces medical devices. It is important to note the impact of inspection results on the organization’s operations. The ...

Harness the Power of AI in GxP – East 2026 brings together industry leaders, innovators, and compliance professionals to explore the evolving role of Artificial Intelligence in regulated life sciences ...

Within regulated environments like pharmaceutical and medical devices, there should be consistent evidence to prove the effectiveness of the manufacturing process in producing reliable products. The ...

On April 2, 2026, the FDA issued a warning letter that should be on the desk of every Quality leader in life sciences. It cites several familiar deviations — but embedded in the findings is something ...

Think about that for a moment: Do you wait until every bit of information is validated and proven before you act? Or do you make the best judgment possible with the information you have so you can ...

As the FDA and other regulatory bodies raise the bar for software validation in healthcare and life sciences, computer software assurance (CSA) activities are becoming increasingly critical to ...

In the highly regulated pharmaceutical industry, Project Management Office (PMO) governance ensures that projects align with compliance requirements and organizational goals. Given the FDA’s stringent ...

Innovations and Emerging Technologies in the Regulated Environment of Pharma Effective training programs are essential for maintaining compliance, improving operational efficiency, and ensuring data ...

When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...

Join us at 2024 Medical Device Innovation Consortium (MDIC) Quality Summit, Where you will learn about adoptable cutting-edge practices to maximize the impact of investing in quality across your total ...

The Sarbanes-Oxley Act (SOX) is a U.S. law that was passed in 2002 to protect investors by preventing fraudulent accounting and financial practices at publicly traded companies. The law's purpose is ...