Design Validation Protocol and Acceptance Criteria for Chromatographic Methods to meet ICH requirements


This Design validation 4 hour session will discuss how to write validation protocol and determine acceptance criteria. It will also explain the systematic approach to validate analytical procedures.

Areas Covered in the Seminar:

Module I. Regulatory Requirements for Analytical Test Methods ( 40 mins)
Drug Development Process
cGMP requirements for analytical test methods
Review ICH Q2 A&B guidelines for method development/validation
Module II Development and Validation Stability Indicating Methods ( 35 mins)
Design method specificity through forced degradation activities
Discuss validation characteristics
Module III. Designing Method Validation Protocols ( 35 mins)
Establish Method Validation Protocol
Establish Method Validation Protocol
Module IV. Managing Validation Data for Quality and Compliance ( 55 mins)
Design Phase-appropriate method validation
Handling validation failure.

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