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Biopharmaceutical Drug Development: Quality, Regulatory, Manufacturing

Analysis and Characterisation 1 / 2

Analytical Procedure Development 26 / 45

Specification Setting 5 / 13

Method Validation 7 / 14

Pharmaceutical Manufacturing 0 / 0

Pharmaceutical Data Integrity 0 / 0

Pharmaceutical Generative AI 0 / 0

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Statistical Tools & Software for Analytical Development

By Event Participant, Sep 09

Method Validation

184

By Quality Expert...

3 months ago

Method Comparability and Statistics for Analytical Development

By Event Participant, Sep 09

Method Validation

150

By Quality Expert...

3 months ago

Equivalence Testing

By Event Participant, Sep 09

Analytical Procedure Development

146

By Quality Expert...

3 months ago

Bridging of methods or critical materials

By Event Participant, Sep 09

Method Validation

136

By Quality Expert...

3 months ago

Vendor support when updating analytical procedures

By Event Participant, Sep 09

Analytical Procedure Development

132

By Quality Expert...

3 months ago

Instruments updates and method validation

By Event Participant, Sep 09

Analytical Procedure Development

155

By Quality Expert...

3 months ago

Established conditions CGT

By Event Participant, Apr 18

Analytical Procedure Development

314

By Quality Expert...

3 months ago

Enhanced Approach and ICH Q14

By Event Participant, Apr 18

Analytical Procedure Development

269

By Quality Expert...

3 months ago

Control Strategy

By Event Participant, Apr 18

Analytical Procedure Development

354

By Quality Expert...

3 months ago

Robustness

By Event Participant, Apr 18

Analytical Procedure Development

304

By Quality Expert...

3 months ago

ATP and filings

By Event Participant, Apr 18

Analytical Procedure Development

270

By Quality Expert...

3 months ago

Method Operable Design Region (MODR)

By Event Participant, Apr 18

Analytical Procedure Development

653

By Quality Expert...

3 months ago

ICH Q14: software-assisted method development

By Event Participant, Apr 18

Analytical Procedure Development

361

By Quality Expert...

3 months ago

Forced degradation testing

By Event Participant, Aug 13

Method Validation

230

By Quality Expert...

4 months ago

MODR (Method Operating Design Region) as method

By Event Participant, Aug 13

Method Validation

275

By Quality Expert...

4 months ago

Is there a need for ongoing method validation?

By Event Participant, Aug 13

Method Validation

165

By Quality Expert...

4 months ago

Batch analytical specifications

By Event Participant, Aug 12

Specification Setting

169

By Quality Expert...

4 months ago

DP testing in Europe vs US market

By Event Participant, Aug 11

Specification Setting

181

By Quality Expert...

4 months ago

What should you do when you lack sufficient sample analyte to cover the entire specifications range?

By Event Participant, Aug 11

Method Validation

200

By Quality Expert...

4 months ago

Number of replicates

By Event Participant, Apr 18

Analytical Procedure Development

278

By Cari - BioQC

5 months ago

Analytical Target Profile

By Tamara Grant, Jan 15

Analytical Procedure Development

817

By Cari - BioQC

5 months ago

CRO or Dossier Holder responsible for Specification

By Event Participant, Jun 12

Specification Setting

269

By Cari - BioQC

5 months ago

Potency Testing

By Event Participant, Apr 18

Analysis and Characterisation

302

By Cari - BioQC

5 months ago

Patient-centric specifications and structure function relationship

By Event Participant, Jun 13

Specification Setting

252

By Quality Expert...

6 months ago

Production specification (NOR) and Regulatory specifications (POR) without DoE

By Event Participant, Jun 11

Specification Setting

491

By Quality Expert...

6 months ago

Risk assessment of Critical Method Parameters (CMPs)

By Event Participant, Apr 18

Analytical Procedure Development

359

By Quality Expert...

6 months ago

Statistical Consultant Agencies and JMP Software

By Event Participant, Apr 18

Analytical Procedure Development

258

By Event Particip...

7 months ago

Established conditions without robustness study

By Event Participant, Apr 18

Analytical Procedure Development

263

By Event Particip...

7 months ago

MODR and method changes

By Event Participant, Apr 18

Analytical Procedure Development

265

By Event Particip...

7 months ago

ICH Q14 software

By Event Participant, Apr 18

Analytical Procedure Development

280

By Event Particip...

7 months ago

Method bridging

By Event Participant, Apr 18

Analytical Procedure Development

340

By Event Particip...

7 months ago

ICH Q14: Enhanced approach vs conventional approach

By Event Participant, Apr 18

Analytical Procedure Development

285

By Event Particip...

7 months ago

ICH Q14: Enhanced approach vs conventional approach

By Event Participant, Apr 18

Analytical Procedure Development

275

By Event Particip...

7 months ago

Mandatory to follow ICH Q14 for method development?

By Event Participant, Apr 18

Analytical Procedure Development

253

By Event Particip...

7 months ago

Practical approach for following ICH Q14

By Event Participant, Apr 18

Analytical Procedure Development

321

By Event Particip...

7 months ago

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