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In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDL ...
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...
In the tightly regulated landscape of FDA-controlled industries, successful navigation through inspections is a cornerstone of organizational success. The Most Common FDA Observations and Prevention Strategies' training addresses the critical need for professi ...
Any laboratory that supports products for sale or use in the United States must follow Good Laboratory Practices (GLP), a comprehensive system that guarantees the validity of results. If you work in pharmaceuticals, chemicals, petrochemicals, and environmental ...
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Proced ...
Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions. In addition, they will be ...
This webinar is designed for managers dedicated to building resilient teams and preventing burnout among their members. As the demands of the modern workplace intensify, whether dealing with high-performing team members or remote workers, burnout is a real thr ...
Computer system validations play a crucial role in the pharmaceutical, medical device and many other FDA regulated industries to ensure the integrity, security, and compliance of critical computerized systems. Inadequate software validations can often time le ...
The FDCPA is a federal act that provides consumers with information around debt collection. Third party debt collectors have to abide by the regulations.
In an era where technological advancements are rapidly reshaping the business landscape, the upcoming webinar spearheaded by Dr. Thea Ducrow, a renowned expert in artificial intelligence (AI) applications in Human Resources, emerges as a pivotal event for indu ...