Joseph Morwald

Krieger Scientific’s founder and CEO discusses how various factors, such as siloed systems and misuse of AI, may be responsible for the increase of warning letters from FDA.

Krieger Scientific's Joseph Morwald on why well-positioned pharma companies treat the FDA as a partner, invest in unbiased third-party oversight, and continuously raise the bar on compliance rather than treating it as a fixed threshold to clear.

Krieger Scientific's Joseph Morwald on why unverified AI-generated documentation in pharma is a complex issue with potentially significant consequences.

Krieger Scientific's Joseph Morwald explains how siloed departments, disconnected systems, and a lack of cross-functional accountability are creating the structural compliance gaps that FDA warning letters keep exposing.

Krieger Scientific's Joseph Morwald on why over-reliance on AI and under-reliance on human expertise is driving the surge in FDA warning letters.