Programs Event: Risk and Science Based Commisioning and Qualification - Key Drivers and Benefits

Risk and Science-Based Commissioning Qualification - Key Drivers and Benefits

Lori Kim, a contributor to the second edition of ISPE Baseline Guide 5.0, will share valuable insights regarding the key benefits and drivers behind the industry adapting to the risk and science based C&Q. Her presentation will focus on how companies can adapt their validation strategies to be risk-based and align with best practices in the industry. 

Drawing on her extensive experiences, 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 risk and science based C&Q approaches into your validation frameworks.

Agenda:

5:30 - 6:30 PM - Registration and Networking (Two drink tickets then cash bar)
6:30 - 7:00 PM - Dinner served
7:00 - 8:00 PM - Presentations

This event is also being offered "virtually" - see ticket options for pricing.

Should you need to cancel after signing up for this event, a full refund of your ticket price will be available up until one week prior to the event (end of day, October 30). After October 30th, should you need to cancel your original purchase price will be considered as a donation to help offset the cost of running future ISPE-DVC events.

Speaker:

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

Location:

Philadelphia Distilling

25 East Allen Street, Philadelphia, PA 19123

Thank you to our sponsors for this event: