CGMP’s – Why Are We Still Getting It Wrong?

Presented by Karen Zimm, Associate Director for Janssen Pharmaceuticals and Renée Phillips, Associate Director of Global Regulatory Affairs at Janssen Research & Development Top Reasons to Attend: • What does FDA continuously cite on 483?• Why does industry make the same mistakes over and over?• Possible systemic reasons• Contributing factors CGMP’s – Why Are We […]

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Presented by Karen Zimm, Associate Director for Janssen Pharmaceuticals and Renée Phillips, Associate Director of Global Regulatory Affairs at Janssen Research & Development Top Reasons to Attend: • What does FDA continuously cite on 483?• Why does industry make the same mistakes over and over?• Possible systemic reasons• Contributing factors CGMP’s – Why Are We […]
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