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Medicinal-Pharmaceutical Chemistry

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Technological University Dublin

2023

Good manufacturing process

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Quality Reborn, Anders Vinther Dec 2023

Quality Reborn, Anders Vinther

Level 3

It is time for Quality leaders to not only fulfill the traditional role of ensuring cGMP compliance within the company but also take the Quality profession to the level of business leadership like Deming did in Japan after World War II. FDA has recently stated that they have low confidence in quality management maturity of the pharmaceutical industry.

For quality leaders to also become good business leaders we must educate them in ways that are different from what we currently do. The education should be in the 6 areas

  • Visibly Demonstrating Responsibility of Quality
  • Risk-Informed Decision Making and Communication
  • Engaging …