Podcast – Pharma Trends – The Return of FDA Warning Letters

[PORCAST] Pharma Trends - The Return of FDA Warning Letters

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Simone Ammons was recently invited on The QualiTalks Podcast with Yan Kugel

Yan Kugel is joined by Simone Ammons, a dynamic engineer, technical writer, and entrepreneur who has navigated through diverse industries with finesse. She’s the founder of the QuneUp, a data-driven software tool that reduces equipment downtime and boosts productivity in the pharmaceutical industry. In this episode, we will be discussing data and FDA warning letters trends across the years with Simone.

See Episode On The QualiTalks Podcast

Key Takeaways from the Episode

  1. The importance of proper record-keeping and adherence to procedures in the pharmaceutical industry.
  2. The impact of digital solutions on documentation and the need for thorough execution of procedures.
  3. The challenges faced by the industry in the aftermath of the pandemic and the importance of upholding standards and regulations.

Episode Chapters:

  • Guest Introduction: Simone Ammons (0:00 – 2:00)
  • Simone’s Career Journey (2:01 – 5:00)
  • FDA Warning Letters Trends Analysis (5:01 – 10:00)
  • Impact of the Pandemic on the Pharmaceutical Industry (10:01 – 15:00)
  • The Importance of Human Interaction in Digitalization (15:01 – 20:00)
  • Conclusion and Closing Remarks  (20:01 – 25:00)

What is QuneUp®?

QuneUp® is a data-driven software tool that reduces equipment down time by enabling access to critical data.

QuneUp® is the brainchild of a Process Engineer who was frustrated with rarely having the critical process equipment data they needed at the right time.

Every minute spent digging for equipment specification sheets and manuals, was a minute that the production line was down – racking up costs for the company.

Just like a plane being on the ground, it costs money whenever a production line is down for any period of time.

QuneUp® gets to the root of the issue by empowering all members of your team with accurate data in a snap.

With QuneUp®, all you need is your cell phone or camera-enabled device to gain immediate access to all the equipment data you need to keep production running.

QuneUp® shortens the cycle of equipment downtime with immediate access to equipment info and data bringing the equipment back online as quickly as possible.
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