GMDP-colleen-hittle

What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain business as close to normal as possible.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Colleen Hittle, founder of ProVeritas Partners, who brings years worth of knowledge and experience in the regulatory environment of healthcare and life sciences. Colleen provides listeners with guidance and support for engaging in virtual auditing and navigating the post-COVID digital world of compliance.

 

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Some highlights of this episode include:

  • Early on during the COVID-19 pandemic, notified bodies were more willing to adopt virtual audits as a way to continue conducting business. However, it took the FDA much longer to accept virtual audits to do business.
  • EUA Requests: What’s taking so long? FDA received about 5,000 submissions. These products should be maintained in the marketplace in a compliant way to ensure public safety.
  • Auditors face challenges performing virtual FDA inspections and ISO audits, including the opportunity to interact and think out loud.
  • Tips, Tricks, and Tools: Face-to-face video technology requires a fair amount of trust, confidence, and transparency in an audit.
  • Companies preparing for an audit involves technology backup and workarounds. Basically, prepare the same way as any on-site audit.   
  • Auditors need to adapt by being direct and emote differently. Pay attention to non-verbal communication, such as body language, tone, and facial expressions. 
  • Virtual audits are expected to continue post-pandemic—even to the detriment of auditors. What are the quality assurance processes to ensure that virtual audits are as effective and successful as they can be?
  • FDA takes risk-based approaches related to inspections due to compliance performance and adverse events. Medical device companies should promptly respond to complaints, recalls, and 483 observations.

 

Links:

ProVeritas Partners

International Organization for Standardization (ISO)

U.S. Food and Drug Administration (FDA)

FDA - Emergency Use Authorization (EUA)

FDA - Medical Device Single Audit Program (MDSAP)

FDA - 483 Inspection Observations

MedTech True Quality Stories Podcast

2021 State Of Medical Device Virtual Summit

Greenlight Guru YouTube Channel

Greenlight Guru

 

Memorable Quotes from Colleen Hittle:

“Early on, many of the notified bodies got on board with the use of virtual audits and other kinds of remote-type monitoring, data gathering.”

“FDA just took much longer. To be fair, they were also pretty busy with other public health considerations during the early days of the pandemic.” 

“There’s no substitute for the interaction, viewing the facility, just taking it all in. It’s the forest in the trees, so to speak.”

“Auditing is never just about a document, but it’s looking at the document in context. Meaning the objective evidence against the broader QMS, against the facility and the people. It’s the whole system. You miss that in a virtual audit.”


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