Change Control is a necessary Quality Management system process for Life Sciences and Manufacturing Companies, given the highly regulated nature of their industries. Change Control provides proper ...

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 ...

In the realm of computer software assurance (CSA), the landscape is evolving at warp speed. Traditional approaches, such as Computer Software Validation (CSV), are giving way to more agile and ...

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 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 ...

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 ...

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 ...

In today's ever-evolving regulatory landscape, ensuring your compliance documentation is accurate, accessible, and effective is crucial. Continuous improvement in compliance documentation entails ...

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 ...

Laboratory University contains 3 amazing events at one location! Each event contains a packed agenda with multiple sub-tracks of current regulations, industry trends and key areas of interest. Create ...