TECHNICAL MODULAR SEMINAR

Nitrosamines After the Initial Assessment

When Does a Change Trigger Reassessment and How Should Impact Be Evaluated

ABOUT THE COURSE

Post-approval changes require disciplined technical evaluation over two focused days where reassessment triggers, scientific rationale, and testing decisions remain consistently supported. This two-day seminar builds a structured approach for evaluating lifecycle changes, reassessment requirements, control strategies, and technical justification across evolving nitrosamine risk scenarios.

The seminar progresses from identifying reassessment triggers arising from lifecycle changes to evaluating their technical significance using current regulatory and scientific approaches. It then advances into analytical justification, NDSRI assessment, control strategy selection, and long-term monitoring practices that support consistent lifecycle management across changing products and manufacturing environments.

Designed for organizations managing product lifecycle changes, nitrosamine risk assessments, regulatory submissions, and scientifically justified change control decisions.

MODULES COVERED over two days

Each of the 8 Modules will cover practical approaches in detail.

Determining When Nitrosamine Reassessment Should Be Initiated
Supplier Changes, Raw Material Changes, and Excipient Changes
Process Changes, Synthetic Route Modifications, Reagents, Catalysts, and Solvents
Formulation Changes, Manufacturing Transfers, and Other Product Lifecycle Changes
Evaluating Change Impact and Establishing Reassessment Requirements
Confirmatory Testing Versus Purge-Based Scientific Justification
NDSRI Assessment and Application of CPCA Principles
Testing Strategies, Control Strategies, Mitigation Measures, and Ongoing Monitoring Expectations

Course Director

G. Sundar

G. Sundar brings more than 35 years of pharmaceutical quality, regulatory, analytical, and manufacturing experience spanning API, formulation, CRO, and quality systems. His extensive work implementing international regulatory expectations, conducting hundreds of GMP audits, and delivering advanced technical training equips him to guide detailed lifecycle decisions involving nitrosamine reassessment, change management, and regulatory justification.

FDB3537

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