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 ...
What is the difference between a Change Management plan and a Communication plan? A Change Management plan is the vehicle that carries people through the change journey. A Communication Plan is the ...
As the Lifesciences (Pharma, Med Tech, Bio Tech) industry continues to undergo transformations with increasing complexity of its operations, project managers stand at the intersection of innovation ...
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 ...
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 ...
Navigating FDA 21 CFR Part 11 compliance requires a strategic approach to Computer System Validation (CSV)and Computer Software Assurance (CSA). Title 21 of the Code of Federal Regulations establishes ...
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 ...
Multilingual and global requirements refer to the need for businesses and organizations to operate across different languages and regions while adhering to diverse regulatory standards. These ...
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 ...
In this session, we will explore Stage 2 of OCM: Adaption exploring its meaning, differentiation from acceptance, methods for fostering readiness, and insights into resistance. We’ll also uncover the ...
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