Nitrosamines After the Initial Assessment: When Does a Change Trigger Reassessment and How Should Impact Be Evaluated
GROUP SAVINGS: Get your team to attend for just $490.
Individual registrations available too.
Make Clear Reassessment Trigger Decisions to Strengthen Testing and Control Strategy Justification.
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.
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
Designed for Organizations managing product lifecycle changes, nitrosamine risk assessments, regulatory submissions, and scientifically justified change control decisions.
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.
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Customized training is also available through TalkFDA Elite Training Labs.
This topic can also be delivered as a customized session for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.
TalkFDA Elite Training Labs