Uncategorized ICH Q9 Quality Risk Management in Pharma

Introduction: ICH Q9 In the highly regulated pharmaceutical and medical technology (medtech) industries, maintaining quality standards is a top priority. Quality Risk Management (QRM) is a systematic process for identifying, assessing, controlling, communicating, and reviewing risks to the quality of a product. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use […]

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Webinars

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Webinar – Proactive vs. Reactive Quality: Building a Business Case for Quality Investments
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Webinar – Make MedTech Postmarket Intelligence Work for You
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Webinar – Calculating the Cost of Quality for Life Sciences: Perspective From a Former FDA Investigator

Reports

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Report – Analysis of FDA 483 issued to Cipla Limited Redica Systems August 9, 2024
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Report – Analysis of FDA 483 issued to Jiangsu Hengrui Pharmaceuticals Redica Systems July 10, 2024
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Report – Aurobindo’s Quality Problems: A Timeline of Regulatory Actions and Recalls Jon Falker June 20, 2024

Assessments

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Assessment – FDA Investigator Snapshot
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Assessment – Site Snapshot

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