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Biopharmaceutical Drug Development: Quality, Regulatory, Manufacturing
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Analysis and Characterisation

E.g. Glycosylation, Managing HCPs, Protein Purity & Control, Biosimilars

 
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Analytical Procedure Development

E.g. ICH Q14, Analytical Quality by Design (AQbD), Analytical Target Profile (ATP), Process Analytical Technology (PAT)

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Method Validation

E.g. ICH Q2, Validation vs Qualification, Analytical Target Profile (ATP)

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Pharmaceutical Data Integrity

E.g. ELN, LIMS, CDS, Quality Management Systems (QMS)

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Pharmaceutical Generative AI

E.g. artificial intelligence (AI), machine learning (ML), large language models (LLM)
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Pharmaceutical Manufacturing

E.g. GMP, Batch vs Continuous Manufacturing, Pharma 4.0

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Specification Setting

E.g. ICH Q6B, Critical Quality Attributes (CQAs)

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