ASQ Columbus Section October Meeting

October 14, 2020
1:00 PM - 2:00 PM
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Remote Audits in the World of COVID-19

 

During these uncertain times, ASQ Columbus is sponsoring a webinar in place of the normal October meeting. Hope you can join us!

Click here to Register!

(Note: Register via the link above - you cannot register through ASQ Columbus' website)

 

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.

Fast forward a bit and now many things that we would’ve done in person before are being done remotely. One of these is audits, including, to a certain extent, regulatory audits. Staying away from crowds and social distancing isn’t very conducive to conducting an audit, but when compliance is on the line, organizations have proved their ability to adjust. In this session, we’ll be looking at how remote audits work, some of the tools available to make the process easier, and how regulatory bodies view the concept.

A big part of audits is reviewing documentation. In companies that use paper-based systems, this involves tracking down binders and file folders containing physical copies of documents. Under this system a remote audit would be horrific. For companies that have digitized, auditors can now easily review documentation remotely. Some systems even allow users to give auditors limited access to their systems so they can review documentation at their leisure.

Even regulatory bodies are coming around to the concept of remote audits. The U.S. Food and Drug Administration (FDA) recently changed their policy toward Medical Device Single Audit Program (MDSAP) audits, allowing some facilities to be audited remotely. The documentation they’ve put out so far suggests that companies that haven’t had compliance issues in the past are more likely to qualify for completely remote audits. Regulated industries are waiting further guidance to see how far this might extend.

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.

 

Speaker: Natalie Weber, Quality Engineer, MasterControl

Natalie Weber has almost 10 years of experience working in the life sciences. During her career she’s 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.

 

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