Ep 3: Quality Crisis EXPOSED: How QPs Lead MHRA/FDA Remediation

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The QP Diaries, by AssureBio

Dal Pawar

40 episodes

1 week ago

The QP Diaries is brought to you by AssureBio. Our mission is to inspire and empower the next generation of QA professionals and future Quality Assurance leaders. If you're passionate about quality assurance and eager to learn from those in the industry, we'd be thrilled for you to subscribe and listen. 🌐 Website: www.assurebio.com 📧 Contact: dal@assurebio.com 📱 LinkedIn: https://www.linkedin.com/company/assurebio/ Let's together ensure quality assurance excellence in the pharmaceutical and biotech sectors, one podcast episode at a time!

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Ep 3: Quality Crisis EXPOSED: How QPs Lead MHRA/FDA Remediation

The QP Diaries, by AssureBio

43 minutes 21 seconds

1 month ago

Ep 3: Quality Crisis EXPOSED: How QPs Lead MHRA/FDA Remediation

Learn what really happens when a pharma quality crisis hits. In this QP Diaries deep-dive, we explore how Qualified Persons (QPs) lead GMP remediation, restore MHRA/FDA compliance, fix systemic quality failures, and rebuild a strong quality culture under extreme pressure. Featuring insights from leading QPs in the UK pharmaceutical industry, this episode breaks down the real triggers behind quality system breakdowns, regulatory findings, amber-light warnings, culture issues, CAPA failures, and what it takes to successfully steer a company through remediation.

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📘Download The QP Diaries: The Playbook

Learn from 21 Quality Leaders as they share their real-world experiences — from passing the Viva to leading through crisis and shaping the future of pharmaceutical quality.The QP Diaries: The Playbook brings together lessons, insights, and inspiration from QPs who’ve walked the same path — all in one powerful guide.

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About AssureBio AssureBio unites the world’s Quality leaders, connecting exceptional QPs and QA professionals with organisations that protect patients and elevate global standards. With over 30 years of combined industry experience and more than 350 successful placements across the UK, EU, and North America, we’re trusted partners to pharmaceutical and biotech companies building high-performing Quality teams. Our mission is simple yet powerful — to strengthen patient safety by empowering Quality professionals and helping organisations achieve excellence through trusted talent and expertise.

🌐 www.assure-bio.com

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