"Audits in the World of COVID-19"
Before COVID-19, life sciences companies were dragging their heels when it came to digitization. Many couldn’t imagine a scenario in which they would desperately need to be digitized. The rationale seemed to be that since they’d been doing fine on paper systems for so long, why change? And then the pandemic hit. With remote work becoming the norm, digital systems proved their worth and companies scrambled to adjust.
Key takeaways from this session include:
- How remote audits are conducted and what they include.
- Why digitizing is the only way to perform remote audits.
- Regulators’ attitudes toward remote audits.
Natalie Weber has almost 10 years of experience working in the life sciences. During her career she has worked for companies such as Edwards Lifesciences and Nelson Laboratories. Weber has experience in converting paper-based laboratory systems to an electronic system, validating laboratory equipment and processes, qualification of new cleanrooms, and environmental monitoring of cleanrooms. In her current position at MasterControl, Weber is responsible for hosting customer and ISO certification audits, CAPA and customer complaint processes, software validation, supplier evaluations, document control, change management, and internal audits. She is an ASQ-Certified Quality Auditor and registered microbiologist. Weber has a bachelor’s degree in microbiology from Weber State University.