PharmD, PhD
Co-Founder and CQO, Qlarix | Founder and Managing Director, Pharmity | Risk-Based Quality Management (RBQM) Expert.
20+ years experience in Pharma, Biotech, CROs. Skilled in Quality Management, Good Clinical Practice and Computerised System Validation.
In our previous Risk-Based Quality Management (RBQM) newsletter, we looked at how to identify meaningful risks around each Critical to Quality Factor (CTQF) by clarifying three key elements: what could happen, why it could happen, and what the consequence would be if it does. That step is essential. But once risks have been identified and […]
In our previous issue, we focused on the first foundational step of Risk-Based Quality Management (RBQM): identifying Critical to Quality Factors (CTQFs). That was the starting point. But once a CTQF has been identified, the next question is just as important: What could go wrong around it? This is where risk identification begins. And in […]
In our previous articles, we committed to demystifying the “HOW” of implementing Risk-Based Quality Management (RBQM). Today, we begin with the starting point of that framework: the identification of Critical to Quality Factors (CTQFs). What Regulators Expect: Designing Quality into Clinical Trials The final ICH E6(R3) guideline marks a significant evolution in how quality is […]