Meet the Expert: Dana Votin
We’re shining a spotlight on GCP expert Dana Votin. Learn how she…
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Creating Efficiencies with Data Integrity
Over recent years relations with data and its weight have changed significantly;…
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The Human Factor – Preparing Your Device for Usability Testing
Usability studies that take the "human factor" into consideration are essential for…
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Innovation and Rapid Growth: A Double-Edged Sword
With the breakthrough innovations we’re seeing in modern medicine, companies are facing…
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FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring...
Part four in our recent blog series related to FDA’s guidance document…
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How to Ensure Your Workforce is GMP Compliant
Can you deliver what the Inspector expects? Ensure your team is GMP-ready…
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Fundamentals of Data Integrity for ATMP Development
Advanced Therapy Medicinal Products (ATMPs), or Cell and Gene Therapies (CGT), have…
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Pedaling While Fixing a Flat: Conducting a Good FDA Meeting...
Before using a significant risk medical device in a clinical study, Sponsors…
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