Course Topics Include: – FDA, ICH and USP Validation Requirements – Applying Validation Studies Consistent with Method Purpose – GMP Compliance during Validation – Validation Acceptance Criteria – ...

Realize safe, scalable, and compliant cell therapies by building analytical strategies that exceed regulatory expectations.

Since the introduction of Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP OES) in 1974, and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) in 1980, these techniques have ...

Early Completion of Model-Assisted Designs for Dose-Finding Trials Accurate assessment of a molecular classifier that guides patient care is of paramount importance in precision oncology. Recent years ...

Long-Term Survival and Biomarker Analysis Evaluating Neoadjuvant Plus Adjuvant Relatlimab (anti-LAG3) and Nivolumab (anti-PD1) in Patients With Resectable Melanoma Our study included a broad cohort of ...

In pharmaceutical manufacturing, cleaning validation is an essential stage of verifying that the manufacturing process is suitable. As an integral stage of the cleaning validation program, analytical ...

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications: Together, these systems work in tandem to ...

In the information age, bridging the gap between data and clinical application is crucial. The Center for Clinical and Translational Science (CCTS) is making significant investments in this area. Over ...