Risk and Science-Based CQ - Key Drivers and Benefits

Lori Kim, a contributor to the updated ISPE Baseline Guide, will share valuable insights regarding the forthcoming changes to the ISPE C&Q Guideline. Her presentation will focus on how companies can adapt their validation strategies to be risk-based and align with industry best practices. Drawing on her extensive experience at AbbVie and PSC Biotech, Lori will discuss effective validation approaches and offer practical advice for organizations seeking to enhance their compliance and operational efficiency.

Attendees can expect to gain a deeper understanding of the evolving landscape of validation, as well as actionable strategies for implementing these updates in their own processes. This session promises to be an essential resource for industry professionals looking to navigate the complexities of validation in a rapidly changing regulatory environment.

Lori's unique perspective will help attendees grasp the importance of a risk-based approach, ensuring that their validation efforts not only meet compliance requirements but also contribute to overall quality and safety in biopharmaceutical manufacturing. Join us to learn how to stay ahead in the field by integrating these updated guidelines into your validation frameworks. 

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://biotech.com/ 

LinkedIn:  Lori Kim

Registration Information:

 COST
ISPE Members$70
Non-Member$90
Emerging Leaders/Students$45

Register now!