In vaccine and therapeutic development, accuracy, reliability, and timeliness are critical – and the analytical tools used should meet those same standards. When selecting new technology for a laboratory, it is essential to highlight not only the technical capabilities of the system but the value it brings to scientists, quality teams, and overall organizational goals.
Suppliers operating under an ISO 13485 certified Quality Management System (QMS) understand the importance of tools that support company-wide quality objectives. When looking for analytical instruments, it is best to seek a quality-focused solution with features such as standardized off-the-shelf materials, 21 CFR Part 11-compatible software, and intuitive instrumentation.
Standardization is a cornerstone of quality. In this webinar, we will discuss how integrating vaccine analytical characterization into Quality Control (QC) workflows enhances consistency, efficiency, and traceability, supporting both regulatory compliance and continuous improvement across R&D and manufacturing.
Key Learnings:
- Recognize how a supplier’s QMS benefits its customers.
- Learn how the standardization of quality metrics and analytics reduces development risk, eases validation efforts, and ensures traceability from development to release.
- Learn how the deployment of routine workflows using “off-the-shelf” reagents enhances the consistency, efficiency, and reliability of quality assurance and quality control activities.
- Empower Quality Assurance departments to deploy quality analytics to enable them to meet their quality goals.
- Understand how InDevR’s products have been developed and maintained under an ISO 13485 QMS to meet key challenges faced by the vaccine industry.
Keynote Speaker:
Kelly O'Neil
Director of Quality Assurance at InDevR
Kelly O’Neil completed her bachelor’s degree in psychology at the University of Colorado in Boulder with a research internship focused on attention and reinforcement learning. Pivoting to pharmaceutical research, she worked for Rocky Mountain Poison & Drug Safety, under the Denver Health Medical Center, as a research assistant on the Consumer Health Product Association’s long-term study of children’s cough and cold medication safety.
In addition, she managed the coordination of post market surveillance reporting for a number of contracted pharmaceutical companies. Kelly has worked for InDevR since 2016 and currently serves as the Director of Quality Assurance. She assisted with the clinical and regulatory aspects of InDevR’s 510(k) submission and has managed the company’s ISO 13485 Quality Management System since 2018.
