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 ...
On April 2, 2026, the FDA issued a warning letter that should be on the desk of every Quality leader in life sciences. It cites several familiar deviations — but embedded in the findings is something ...
In highly regulated industries such as pharmaceuticals and biotechnology, manufacturing is about much more than producing a product. Companies must prove through clear documentation and testing that ...
The regulatory environment for manufacturers of medical devices in the United States is about to change in a significant way. The implementation of the FDA QMSR final rule has led to the modernization ...
This panel discussion will focus on three major guidance initiatives currently shaping the future of computerized systems compliance, featuring insights from ISPE Steering Committee Americas members.
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