A technical deep-dive into post-approval change management for nitrosamines — covering reassessment triggers, ICH M7 purge assessments, NDSRI/CPCA classification, control strategy selection, and global regulatory alignment.
Includes live access & recording
A nitrosamine risk assessment is often straightforward when the process, materials, suppliers, and product remain unchanged. The truly difficult decisions begin during lifecycle management when something changes — a new supplier is introduced, a reagent is replaced, a manufacturing site is transferred, a formulation is modified, or an unexpected analytical result is reported.
Teams must determine whether the existing risk assessment remains scientifically defensible or whether a formal reassessment, confirmatory testing, or additional control strategies are required. This technical webinar focuses entirely on the critical decisions that follow post-approval change.
Participants will learn how experienced pharmaceutical organizations evaluate reassessment triggers, determine the significance of supplier, process, formulation, and manufacturing modifications, and decide when physical testing is strictly warranted versus when a scientific rationale suffices.
Few life science organizations still struggle with the initial phase of identifying potential nitrosamine risks. The greater, ongoing operational challenge is determining exactly what to do after a change occurs — across Change Control reviews, supplier evaluations, deviation investigations, APR/PQR cycles, and global regulatory submissions.
The answer is rarely obvious or binary. Some lifecycle changes necessitate immediate confirmatory testing, revised specifications, or a comprehensive overhaul of the regulatory dossier. Others require only a highly robust, documented scientific rationale.
This webinar demystifies how those decisions are made — covering USFDA, EMA, Health Canada, ANVISA, and TGA expectations in a single, harmonized technical session.
By the end of this intensive 2-hour session, participants will be able to apply rigorous, audit-ready decision frameworks to nitrosamine reassessment across the full product lifecycle.
Determine when a post-approval change triggers a mandatory nitrosamine reassessment versus when the existing Step 1 assessment remains regulatory-defensible.
Evaluate the impact of supplier shifts, raw material variations, excipient nitrites/amines, process modifications, and manufacturing site transfers on nitrosamine risk profiles.
Assess whether laboratory confirmatory testing is legally necessary or whether a robust, data-driven scientific justification can independently support the change control.
Apply ICH M7 semi-quantitative purge scoring concepts to support change impact evaluations and justify the absence of routine downstream testing.
Distinguish minor lifecycle changes from material changes that fundamentally alter the thermodynamic or kinetic potential for nitrosamine formation.
Evaluate complex NDSRIs using current CPCA-based structural feature scoring when compound-specific rodent carcinogenicity data is unavailable.
Select and defend appropriate control strategies (Options 1–4) based on process capability, process understanding, and available analytical LOQ.
Build audit-ready, defensible reassessment rationales capable of passing global regulatory reviews, health authority inspections, and annual PQR audits.
Four critical technical areas that define how leading pharmaceutical organizations manage nitrosamine risk through continuous product lifecycle changes.
Learn the exact regulatory and technical boundaries where an existing nitrosamine risk assessment is rendered obsolete — and how to build SOPs that interface Change Control with your Nitrosamine Core Team.
Understand when laboratory testing is non-negotiable and when a purge-based scientific justification can legally bypass analytical verification — including how to document it to withstand EDQM and Health Canada scrutiny.
Deep-dive into the CPCA scoring system adopted by FDA, EMA, Health Canada, ANVISA, and TGA — including step-by-step potency category assignment and AI limit determination for complex NDSRIs.
Navigate the full range of ICH Q6A control options (Options 1–4), formulation mitigation engineering strategies, and continuous lifecycle monitoring integration into your APR/PQR program.
A structured, module-by-module deep-dive covering every critical dimension of nitrosamine reassessment, NDSRI classification, and post-approval change management.
Regulatory paradigm shift, trigger definitions, cross-agency comparison (USFDA, EMA, Health Canada, ANVISA, TGA), and internal SOP workflow design.
API/KSM supplier risks, excipient-driven nitrosation, amine component assessment, and proactive supplier qualification strategies.
Altered kinetics and thermodynamics, reagents and catalysts, solvent recovery risks, and azide mitigation pitfalls.
Solid state vs. liquid phase reactions, primary packaging risks, site transfer impact, and OOS/OOT stability investigation management.
Risk categorization matrix, scientific rationale development, and the impact of newly published or lowered Acceptable Intake (AI) values.
Non-negotiable testing thresholds, ICH M7 purge factor framework, scoring logic, and dossier documentation that withstands reviewer scrutiny.
Step-by-step CPCA scoring — alpha-carbon hydrogen counts, deactivating/activating features, potency category assignment (Cat 1–5), and AI limit determination.
LC-MS/MS and GC-MS/MS method selection, ICH Q6A Options 1–4, formulation mitigation engineering, and APR/PQR continuous lifecycle compliance.
Senior technical professionals, managers, and directors across global life sciences organizations involved in quality, regulatory, analytical, process, and manufacturing functions.
Quality Assurance (QA) Departments
Regulatory Affairs & Regulatory CMC Departments
Quality Control & Analytical Development Departments
Process Chemistry & Technical Services Departments
Formulation Development Departments
Manufacturing Operations Departments
Supplier Quality Departments
The initial phase of nitrosamine risk assessment — driven by regulatory deadlines from the USFDA, EMA, Health Canada, ANVISA, and TGA — required pharmaceutical organizations to systematically evaluate their products and processes for potential nitrosamine formation pathways. While many organizations have successfully completed these foundational assessments, the ongoing challenge is now one of continuous lifecycle management under ICH Q9(R1) and ICH Q12 frameworks.
Post-approval changes are inevitable. Supplier consolidations, raw material substitutions, process optimizations, formulation modifications, and manufacturing site transfers are routine events in pharmaceutical product lifecycle management. Each of these changes carries the potential to alter the thermodynamic or kinetic conditions that govern nitrosamine formation — and regulatory agencies have made clear that organizations bear responsibility for continuously evaluating whether such changes render existing risk assessments obsolete.
The complexity of these decisions is compounded by the evolving scientific and regulatory landscape. Acceptable Intake (AI) limits continue to be revised as new toxicological data emerges. The Carcinogenic Potency Categorization Approach (CPCA) for NDSRIs has been harmonized across multiple regulatory jurisdictions. ICH M7 purge factor methodologies have been refined. Each of these developments can trigger retroactive impact on previously approved products and processes.
This session provides the technical depth and decision-making frameworks that pharmaceutical quality, regulatory, and analytical professionals need to navigate these challenges with confidence — producing documentation and rationales that are scientifically defensible, globally harmonized, and inspection-ready.
G. Sundar is a quality practitioner with over 35 years of experience in Quality Assurance, Quality Control, Bioequivalence, and Pharmaceutical Regulations. His quality management experience covers the implementation of quality tools in bulk drugs, formulation companies, and CROs. He is an expert in Total Quality Systems as per GLP, GDP, and EMEA, USFDA, MHRA, MCC, TGA, ANVISA, and Japan guidelines.
He has conducted more than 200 GMP/GLP audits including Q10 & Q11 implementation, 50 Formulation Contract Manufacturing Units (all types of formulations), 10 Contract Research and Analytical laboratories, and 10 Clinical Research CROs. He has also conducted 1,000+ trainings across Asia, US, EU, Middle East, and South-East Asia.
Mr. Sundar Ganesan is the Director and Senior Consultant at PharmQA Compliance Services.
Don't miss this intensive 2-hour technical session on nitrosamine reassessment, NDSRI/CPCA classification, and post-approval change management across global regulatory frameworks.