Annex 11 Revision, CSA, and the New Testing of GxP Systems GPG: An Author Panel Perspective March 19, 2026- March 20, 2026 KENX Validation University and Pharmaceutical Engineering Summit 2026 ...

AI is no longer a future concept in lifesciences, it’s actively being deployed across business processes from regulatory submissions to manufacturing monitoring to quality operations. But while ...

Online or The DoubleTree by Hilton, 237 s Broad Street, Philadelphia, Pennsylvania GMP University – Hybrid Conference ...

Corrective And Preventive Action (CAPA) is often discussed as it is an alarming issue for the life sciences industry. Organizations consider its importance and try to deal with it better as CAPA's are ...

The US Food and Drug Administration (FDA) is responsible for protecting public health by ensuring medical devices' safety, efficacy, and quality. The agency has developed a rigorous medical device ...

There may be some misunderstanding surrounding FDA 21 CFR Part 11 when it comes to regulatory compliance for manufacturers of medical devices. We have discovered a major pitfall here: Many businesses ...

Companies in the life sciences industry face challenges in developing and maintaining data integrity due to complex validation documentation. Maintaining data consistency, accuracy, and integrity ...

From hearing aids to ultra-tech pacemakers, the medical device industry is a ground-breaking and innovative field full of opportunities. Though the manufacturers are passionate about delivering ...

FDA issues warning letters to avoid compliance. Warning letters are issued when the FDA finds that a company from the life science industry is out of its way with the regulatory standards in quality ...

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 ...

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 ...

Packaging and sterilization validations are a critical step in the development and manufacturing of medical devices, as they ensure patient safety, regulatory compliance, product quality, and the ...