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02-FDA-PQRI Symp Oct 15.Kinghorn

01 PQRI Lee Botanicals 20151

04 Wesdyk Qm Cci for Pqri

03 Monteagudo How Quality Risk Management Can Enable a More Effective Pharmaceutical Quality Final

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05 Feely Change Management ISPE Oct 15 v4

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Product Monitoring & Post-Approval Lifecycle Management of Biotech Products

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2010 Process Drift Chodankar

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Quality by Design and Extractable and Leachable Testing

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2010 SANOFI Managing Change in Manufacturing Hamilton

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2010 TEVA Process Drift Ben-Anat

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FMEA Training Guide

Guideline on stability testing for applications for variations to a marketing authorisation

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Design of Experiments in Protein Production and Purification DoE 2014