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Biopharmaceutical Drug Development: Quality, Regulatory, Manufacturing

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Analysis and Characterisation 1 / 1

Analytical Procedure Development 23 / 24

Specification Setting 0 / 0

Method Validation 1 / 1

Pharmaceutical Manufacturing 0 / 0

Pharmaceutical Data Integrity 0 / 0

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Control Strategy

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Statistical Consultant Agencies and JMP Software

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Established conditions without robustness study

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

ATP and filings

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Enhanced Approach and ICH Q14

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

MODR and method changes

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Number of replicates

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Method Operable Design Region (MODR)

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Robustness

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

ICH Q14 software

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Established conditions CGT

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Method bridging

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Risk assessment of Critical Method Parameters (CMPs)

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

ICH Q14: software-assisted method development

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

ICH Q14: Enhanced approach vs conventional approach

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

ICH Q14: Enhanced approach vs conventional approach

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Mandatory to follow ICH Q14 for method development?

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Practical approach for following ICH Q14

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Applying ICH Q14 retrospectively

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Assessment of assay criteria

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

ICH Q14: characterisation vs release method

By Event Participant, Apr 18

Analytical Procedure Development

By Event Particip...

1 month ago

Trending vs Validation

By Event Participant, Apr 18

Method Validation

By Event Particip...

1 month ago

Potency Testing

By Event Participant, Apr 18

Analysis and Characterisation

By Event Particip...

1 month ago

ICH Q14

By Jeroen Reiniers, Dec 11

Analytical Procedure Development

123

By Tamara Grant

4 months ago

Analytical Target Profile

By Tamara Grant, Jan 15

Analytical Procedure Development

196

By Tamara Grant

4 months ago

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