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Advance Your Scientific and Regulatory Competence
Empowering pharma professionals through expert-led training on ICH guidelines, impurity assessment, nitrosamine control and regulatory compliance.
Ultra Bio Instruments offers specialized training programs that equip professionals with the skills and regulatory insight required to meet evolving global standards. Our modules are curated by domain experts with deep experience in impurity control, regulatory strategy and analytical sciences. Each program combines scientific theory with real-world application – ensuring knowledge that is both compliant and practical.
Customized Training Sessions by Subject Matter Experts
Mutagenic Impurities and ICH M7 Requirements
• Understanding impurity classification, (Q)SAR analysis, and acceptable limit determination.
• Regulatory updates and current challenges.
Nitrosamine impurities in API and dosage forms
• Identification, evaluation, and mitigation aligned with latest global guidance
• Safety evaluation and toxicity assessment
• Documentation for regulatory submission
Extractables & Leachable Qualification (ICH Q3E)
• Regulatory requirements and scientific context.
• Guidance on experimental design, data interpretation
• Analytical techniques used for E&L studies
Elemental Impurities Assessment (ICH Q3D)
• Identification, risk assessment, and control of impurities as per ICH guidelines
• Understanding permitted daily exposure (PDE) values,
Forced degradation Studies
• Comprehensive forced degradation studies for API and dosage forms.
• Degradation characterization. Analytical strategies
Excipient Qualification
• Methods for qualifying specific levels of excipients in drug products
• Technical standards needed to approve and manage excipient suppliers.
Training Format
Flexible, Practical & Impact Oriented
- Customizable Programs - Designed for organization-specific needs and product categories.
- Flexible Delivery – Available as classroom sessions, virtual training, or blended modules.
- Real-World Case Studies – Focused on practical learning through regulatory examples.
- Certification of Completion – Formal acknowledgment of participant competence.
Who should Attend
Ideal for Professionals across Key functions
- Quality Assurance (QA)
- Quality Control (QC)
- Regulatory Affairs
- R&D (Synthesis and Formulations)
- Analytical Development
- Operations
Why Choose Us
- Experienced scientific and regulatory professionals
- Curriculum aligned with ICH, FDA, EMA expectations
- Hands-on learning with proven implementation insights
- Trusted partner for global pharmaceutical organizations
Request a Tailored Training Program
We customize training to align with your organization’s needs, regulatory priorities, and product portfolio.
