Analytical Method - Qualification, Validation & Transfer
  • Day1
Thursday, 18th November 2021

13:30

Test Run and Web Checks

14:30

Welcome Address and Introduction to the Experts
Sanjay Bajaj, CEO & MD, Glostem Private Limited, India

14:50

Select Emerging Requirements w.r.t Method Validation
Saranjit Singh, Ex-Professor & Head, Pharmaceutical Analysis, NIPER, Mohali, India

15:10

Open Discussion/ QA Session

15:15

Significance of Implementing QbD in Analytical Method Development – A Case Study Overview
Trupti Tol, Associate Director - QbD-IPD, Cipla Ltd, India

15:30

Open Discussion/ QA Session

15:40

Analytical Procedure Lifecycle
Bhaskar Kolte, Associate Director - Analytical Research Development, Perrigo, India

15:55

Open Discussion/ QA Session

16:05

Reference Standard Qualification
Chait Wannere, Senior Director, Analytical Development, TCG GreenChem, USA

16:20

Open Discussion/ QA Session

16:35

AMQ, AMV, APT Studies for Analytical Platform Technology (APT) Methods
Stephan O. Krause, Head of Product Quality Group, AstraZeneca Biologics, USA

17:00

Open Discussion/ QA Session

17:15

Rap Session

17:30

Closing Remarks (Prof Saranjit Singh)

17:35

Vote of Thanks (Dr Sanjay Bajaj)

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