Are you GCP Audit and Inspection Ready?
RBQM done correctly can significantly reduce findings. Jo Burmester provides practical hints and tips to prepare your organization for an audit or inspection.
Nov
2021
Jul
2021
How to Build Critical to Quality Trees for Clinical Research
Building Critical to Quality Trees helps you to translate critical study needs and quality drivers into measurable outcomes and processes. Initially, this Lean Six Sigma approach serves as a business tool based on customer needs. Still, it is a helpful method of implementing Quality by Design in clinical research.
Jun
2021
Adverse Event Reporting as an Example of the Risk Assessment Process
Do you find the prospect of Risk Analysis and Risk-Based Quality Management (RBQM) to be daunting? Then bear with us. We shall help you simplify and demystify the process by using an example to illustrate the key steps to consider.