The FDA’s Final CSA Guidance represents a significant step in modernizing validation across the industry. While it brings clarity, many questions remain about interpretation, practical application, ...

The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...

Change Management, as you may know, involves the process and methodology focused on the people side of change. In simple terms, it’s about helping people succeed through change, enabling your ...

In today's rapidly evolving technological landscape, industries such as life sciences, pharmaceuticals, and medical devices are increasingly challenged to maintain regulatory compliance while driving ...

In the realm of Computer System Validation (CSV), risk assessment stands as a cornerstone in ensuring the safety, efficacy, and compliance of software systems, particularly in regulated industries ...

In this 2-part webinar series, attendees will learn insights on JuneBrain’s digital journey in adopting a modern data centric Design Quality and Risk Management System technology. This webinar will ...

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 ...

What exactly is Compliance documentation and how do you know if you are creating clear, concise, accurate content? In the life sciences field compliance documentation is crucial for meeting regulatory ...

PAT tools and technology solutions are continually evolving to become more user-friendly, advanced and reliable. These improvements are making it easier for organizations to adopt and integrate PAT ...

The journey of implementing and validating Veeva Quality Management System (QMS) in life science companies can be a transformative, sometimes challenging, and rewarding endeavor. As a Quality Manager, ...

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 ...