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Lessons from 483s: Essential Strategies for Medical Device Manufacturers 

Lessons from 483s: Essential Strategies for Medical Device Manufacturers 

by Paul Challinor | Apr 3, 2024 | Manufacturing, Medical Devices, Quality and Compliance

Streamline CFR Part 820 compliance for medical devices. Merit for Life Science tackles CAPA, complaints & training for smoother FDA inspections....

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Lessons from 483 Inspections: CFR 21 Part 211

Lessons from 483 Inspections: CFR 21 Part 211

by Paul Challinor | Mar 15, 2024 | Biotech, Business Insights, Digital Transformation, Life Sciences, Manufacturing, Pharmaceutical, Quality and Compliance

In the highly regulated world of drug and biotechnology manufacturing, adhering to FDA regulations is essential not just legally, but also...

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Lessons from 483 Inspections: Navigating FDA Compliance for Drug and Biotech Manufacturers

Lessons from 483 Inspections: Navigating FDA Compliance for Drug and Biotech Manufacturers

by Paul Challinor | Mar 14, 2024 | Biotech, Business Insights, Digital Transformation, Manufacturing, Pharmaceutical, Quality and Compliance

In the biopharmaceutical industry, ensuring public health and product safety is paramount. Regular inspections by the Food and Drug Administration...

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