Description
QbD-Based Pharmaceutical Impurity Control Training | ICH Guidelines & Risk-Based Strategies
Upgrade your expertise with this QbD-Based Pharmaceutical Impurity Control Training, designed to help professionals move from traditional “testing-in quality” to a science- and risk-based approach where impurity control is built into the product and process design.
Aligned with ICH Q8, Q9, Q10, M7, and Q3 guidelines, this course provides a comprehensive understanding of impurity identification, control strategies, risk assessment, and regulatory compliance across the pharmaceutical lifecycle.
Course Overview
Fundamentals of QbD & Impurity Management
- Introduction to Quality by Design (QbD) principles
- Regulatory framework: ICH Q8 (Development), Q9 (Risk Management), Q10 (Pharmaceutical Quality System)
- Integration of impurity guidelines: ICH Q3A/B/C/D & M7
- Defining Quality Target Product Profile (QTPP) for impurity control
Impurity Control Modules
🔹 Chiral Impurities
- Identification, separation, and quantification strategies
- Use of HPLC, GC, and chiral techniques
- Regulatory expectations and best practices
Achiral (Process-Related) Impurities
- Monitoring synthetic and process-related impurities
- Impurity profiling and analytical method development
- Setting acceptable limits and documentation
Isomeric Impurities
- Understanding positional and stereoisomers
- Separation techniques using HPLC, LC-MS, and chiral columns
- Quantification and control strategies
Degradation Impurities
- Forced degradation studies: acid/base, thermal, oxidative, hydrolytic
- Photostability testing and light-induced degradation
- Development of stability-indicating methods
Genotoxic Impurities (ICH M7)
- Identification and control of mutagenic impurities
- Threshold of Toxicological Concern (TTC) and risk-based approaches
- Analytical and in-silico assessment tools
Nitrosamine Impurities
- Regulatory concerns and global guidelines
- Screening, detection, and quantification
- Risk mitigation strategies in manufacturing
Elemental Impurities (ICH Q3D)
- Sources and risk evaluation
- Detection using ICP-MS, ICP-OES
- Limit setting and regulatory compliance
Impurity Control Strategy
- Determining where, how, and at what levels impurities should be controlled
- Use of risk assessment tools (TTC, in-silico models, SAS)
- Purge factor studies for process safety and compliance
- Integration with QbD and lifecycle management
Regulatory Guidelines
- ICH: Q3A, Q3B, Q3C, Q3D, M7, Q8, Q9, Q10
- Global expectations: USFDA, EMA
- Documentation, reporting, and submission readiness
Practical Learning & Case Studies
- 50+ real-world case studies across impurity types
- Analytical method development insights
- Troubleshooting strategies and regulatory tips
- Interview FAQs and expert guidance
Key Learning Outcomes
- Apply QbD principles to impurity control and process design
- Develop robust, compliant impurity control strategies
- Use risk management tools to prioritize and mitigate risks
- Optimize analytical methods using DoE (Design of Experiments)
- Ensure global regulatory compliance with confidence
Who Should Attend?
- Analytical scientists and AR&D professionals
- QA/QC and regulatory affairs professionals
- Pharma R&D and manufacturing teams
- Professionals working on impurity profiling and control
Why Choose This Course?
- Industry-focused, practical approach
- Aligned with global regulatory expectations
- Real-world case studies and hands-on insights
- Career-oriented, job-ready skills
Build expertise in modern impurity control strategies using QbD principles and stay ahead in the evolving pharmaceutical regulatory landscape.
Sessions: 6 sessions (9 hours / 540 minutes each)
Mode of Training: Online (via Google Meet)
Certificate: Yes, a certificate of completion will be provided
Money-Back Guarantee: 30-day money-back guarantee
Outcome:
- Strong foundational knowledge
- Clear career direction
- Improved decision-making for advanced learning
Language: English
Instructor: Dr Pramod Kumar Pandey (PhD in Chemistry) | 31+ years of experience in global and Indian pharmaceutical industries
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