Nudelman ChemTox
Consulting
Training
This service provides practical, hands-on training to professionals and organizations looking to deepen their understanding of impurity qualification and regulatory compliance. Key aspects include:
Delivery Methods
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In-Person Training: On-site sessions tailored to the specific needs of the team or organization, providing real-time interaction and personalized guidance.
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Online Training: Flexible, interactive sessions conducted via virtual platforms, accessible globally and designed for convenience without compromising quality.
Topics Covered
Training modules can be customized to cover a variety of specialized topics, including but not limited to:
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Qualification of Mutagenic Impurities: Guidance on how to assess potentially mutagenic impurities according to the ICH M7 guideline.
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In Silico Methods for Mutagenicity Assessments: Training methods on what to expect and how to imlement computational predictions including QSAR models like Lhasa’s Derek and Sarah Nexus, MultiCase’s Case Ultra, and Instems Leadscope software.
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Risk Assessment of Nitrosamines: Risk of formation of nitrosamines in drug substances and drug products; setting acceptable intake (AI) limit for nitrosamines; using nitrosamine regulatory guidelines.
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Qualification of Non-Mutagenic Impurities: Guidance on qualification and justification of non-mutagenic impurities, following the ICH Q3A/Q3B guidelines.
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Residual Solvents and Elemental Impurities: Techniques for quantification and compliance following ICH Q3C and Q3D guidelines.
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Extractables & Leachables: Training on experimental design, data interpretation, and risk management strategies using current guidances (e.g. PQRI); preparation for publication and compliance with ICH Q3E guideline.
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Excipient Qualification: Methods for qualifying specific levels of excipients in drug products.
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Occupational Health Categorization and HBELs: Establishing OELs, ADEs, and health-based safety thresholds for pharmaceutical operations.
Why Choose Our Training?
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Hands-On Approach: Practical sessions with case studies and real-world examples to ensure participants can apply their knowledge effectively.
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Expert Guidance: Led by industry professionals with extensive experience in impurity qualification, excipient justification, and regulatory sciences.
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Tailored Content: Training programs customized to meet the specific needs of the organization or individual participants.
This service empowers professionals to enhance their expertise, stay updated on regulatory trends, and apply best practices in their workflows.