Good manufacturing practice training programme for Turkish inspectors

Event

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Date

torek, 20 Oktober 2009, All day

Lokacija

European Medicines Agency, Amsterdam, the Netherlands

Documents

Agenda - GMP training program for Turkish inspectors

English (EN) (44.23 KB - PDF)

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Introduction to EU Regulatory system and GMP Inspection system. The Qualified Person - David Cockburn

English (EN) (1.47 MB - PDF)

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EU GMP Requirements - Quality Systems - Bernd Boedecker

English (EN) (405.82 KB - PDF)

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GMP Training Course Quality Control - Lesley Graham

English (EN) (603.79 KB - PDF)

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EU GMP Requirements - Validation - Bernd Boedecker

English (EN) (499.96 KB - PDF)

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EU GMP Requirements - Investigational Medicinal Products - Bernd Boedecker

English (EN) (444.23 KB - PDF)

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Dealing with Quality Defects and Rapid Alerts - David Cockburn

English (EN) (355.57 KB - PDF)

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GMP Training Course Inspections from an industry perspective - Fiona Routley

English (EN) (520.75 KB - PDF)

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EU GMP requirements - Sterile medicinal product - Martin Melzer

English (EN) (3.93 MB - PDF)

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EU GMP Requirements - Biological medicinal product for human use - Martin Melzer

English (EN) (2.44 MB - PDF)

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EU GMP Requirements - Good Distribution Practices - Martin Melzer

English (EN) (2.55 MB - PDF)

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