The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.
During this session, we'll dive into the practical ways AI tools are being integrated into corporate training programs to increase engagement, reduce training fatigue, and ensure regulatory compliance.
In this webinar, you will learn how to take all of your raw data and quickly turn that data into easy to use flexible summary reports using Pivot Tables and Charts.
The MENA region suffers from a Drug & Device Lag, meaning innovative products typically do not reach the market for 10+ years, after they are approved and launched in the U.S. or EU. Because of this, there exists significant opportunity for U.S. and EU developed products, if the regulatory hurdles can be navigated
Stepping into a management role can feel like walking a tightrope-one wrong word, one confusing instruction, and suddenly your credibility feels shaky.
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it.
Post-Market Surveillance (PMS) and Vigilance Reporting for Medical Devices and Combination Products are critical components of regulatory compliance, ensuring ongoing patient safety and product effectiveness after market approval.
In today's dynamic workplace, leaders are increasingly confronted with challenging employee behaviors that can disrupt team harmony, reduce productivity, and escalate conflicts.