• June 16-19, 2025
  • Boston Convention & Exhibition Center

Risked Based Approach Commissioning and Qualification for organizations

Loading

Risked Based Approach Commissioning and Qualification for organizations

Thursday, June 06, 2024
BioProcess Theater
BioProcess Theater
This presentation outlines risk and science-based approaches to Quality Control (CQ) within the pharmaceutical industry, aimed at optimizing efficiency, streamlining processes, and ensuring regulatory compliance. By integrating Quality Risk Management (QRM) into the Commissioning and Qualification (C&Q) processes, manufacturers can proactively identify and mitigate risks through comprehensive system risk assessments and control strategies embedded within system design and verification testing. This method advocates for the incorporation of Good Engineering Practices, fostering flexibility and agility in project execution while minimizing the need for extensive oversight and approval from Quality Assurance (QA) throughout the project lifecycle. Consequently, it facilitates reduced repeat verification testing, leading to expedited project turnaround times and heightened operational efficiency.
Back to Session List

BIO DOUBLE HELIX SPONSORS

Thanks to our sponsors for supporting our mission to drive a revolution to cure patients, protect our climate, and nourish humanity.

Loading

BIO HELIX SPONSORS