Topic

Articles

Industry sees high increase in the use of QTLs.

Quality Tolerance Limits: A Review of Industry Trends

Webcasts

Webinar Date/Time: Mon, Feb 13, 2023 10:00 AM EST


Addressing Operational and Technical Challenges in Home-use Point-of-Care Device Development and Deployment

Study indentifies trends in most commonly used KRIs.

Identifying Important Risk Indicators in Clinical Development

Senior Director, Clinical Strategy, Veeva Systems

With risk-based quality management (RBQM), the industry is uniquely positioned to amend Murphy’s Law and propose something new—“Everything that can go wrong, we can work to identify and prevent.”   

Moving Beyond the Checkbox Approach With Risk-Based Quality Management

Vice President, Clinical Trial System and Auditing QA, RDQ, Bristol Myers Squibb

Director, North and South America, Clinical TrialSystem and Auditing QA, RDQ, Bristol Myers Squibb

Director, Europe and Asia, Clinical Trial System and Auditing QA, RDQ, Bristol Myers Squibb

Advancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.

Clinical Study Audits: The Quality Management Approach

Series Part 3—Methods for early detection of risk and summary.

Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 3)

Series Part 2—The process of defining QTLs.

Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 2)

Series Part 1—Introduction and the relationship between QTL and KRI.

Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 1)

Patrick Hughes is Co-Founder, Chief Commercial Officer, CluePoints 

COVID-19 may have accelerated the adoption of RBQM, but it is the intrinsic benefits that are cementing its continued use.

Unlocking the Potential of Risk-Based Quality Monitoring

Developing a higher level of critical thinking can create a comprehensive risk story and properly direct mitigations throughout your organization. 

Risk-Based Monitoring