Dr. Stephanie Harden is the manager of Waters global small molecule pharmaceutical market segment. Stephanie has a passion for enabling world class pharmaceutical development and has been instrumental in helping customers to transform the way their organizations operate. She is a highly cited author with a PhD in Chemistry from the University of Bristol, UK.
Audit readiness isn’t a last-minute activity triggered by validation or inspection. It’s established much earlier, at method design, through the scientific understanding, risk-based control, and documentation needed to demonstrate that a method is fit for purpose and capable of performing consistently over time. If those elements aren’t built in from the outset, gaps are likely…
For contract organizations working in the pharmaceutical industry, operating at peak performance and capacity is a vital step towards delivering life-saving therapies.
Hear from Dr. Fadi Alkhateeb, a Waters Senior Separations Scientist on the approach and tools used to design and develop fit-for-purpose methods.