Risk and Science-Based CQ - Key Drivers and Benefits
Risk and science-based commissioning and qualification (C/Q) focus on optimizing resource allocation by prioritizing critical systems, ensuring efficiency and compliance in regulated industries. This approach identifies and mitigates potential risks early, preventing issues that could affect product quality or safety. Using scientific principles for decision-making enhances accuracy and reliability, leading to better regulatory compliance and faster time to market. Overall, it promotes continuous improvement, operational excellence, and heightened confidence in system performance. Agenda:
- 5:30 - 6:30 PM Registration & Networking
- 6:30 - 7:00 PM Dinner served
- 7:00 - 8:00 PM Presentation
Speakers:
Lori Kim | Vice President of Global Technical Operations
PSC Biotech Corporation
With over 33 years of experience in the pharmaceutical and bio-pharma industry, Lori Kim has held multiple engineering leadership roles in companies like Abbott and AbbVie. Following her retirement from AbbVie in 2022, she became the Vice President of Technical Operations at PSC Biotech in 2023. In this role, she leads risk-based C&Q, digital validations, project management, and other key engineering functions. Kim is a co-author of the ISPE Baseline Guide Vol 5, Commissioning & Qualification, 2nd Edition and has served as Chair of the ISPE CQ COP Steering Committee. She earned her BS in Chemical Engineering from the University of Illinois, Urbana-Champaign.
https://pscbiotechne.my.canva.site/professional-services
https://biotech.com/ LinkedIn: Lori Kim
Registration Information:
| COST | |
|---|---|
| ISPE Members | $70 |
| Non-Member | $90 |
| Emerging Leaders/Students | $45 |