One-Day Training on Analytical Method Validation
This one-day course provides the foundation on which to build a practical approach to validating an analytical method. We work through each of the main validation parameters, looking at how these are applied in a practical environment to design test samples and set meaningful limits.
Although ICH Q2 guidelines form the key reference, this course focuses on practical applications, particularly chromatographic and spectroscopic analysis. The course includes workshop-based learning with real analytical data to gain experience in troubleshooting common validation failures.
FOR JUST RS 999/-
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What You Will Learn:
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Overview of the validation process
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Selection of performance characteristics
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Defining analyte concentration for various preparations
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Preparation of validation protocol (Assay, RS, Dissolution, & Residual solvents)
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Essential statistical tools
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Method validation as per ICH & ANVISA
The Training Program is on 1st DEC, 10:00 AM - 04:00 PM
Who Should Attend This Training Program
This training is ideal for professionals in Analytical Development, Pharmaceutical Development, Quality Control, Quality Assurance, Regulatory Affairs, and Project Management.
Training Content
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Relationship with Method Development
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Specificity/Selectivity
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Precision
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Range
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Potential Challenges & Way Forward
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ICH Guidelines
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Forced Degradation
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Accuracy
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Sensitivity (LOD, LOQ)
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Typical Experimental Approaches
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Validation Protocol
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Peak Purity
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Response/Linearity
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Robustness
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Workshop Exercises
The Training Program is on 1st DEC, 10:00 AM - 04:00 PM
Training Content
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Understand method validation and its requirements
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Apply statistical tools effectively during validation
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Define analyte concentrations based on performance characteristics
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Link method validation with method development
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Enhance problem-solving with advanced troubleshooting techniques
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Engage in practical, hands-on exercises and case studies
The Training Program is on 1st DEC, 10:00 AM - 04:00 PM
Meet Your Trainer
Mr. Bhaskar Napte (Founder of Pharma Growth Hub)
Bhaskar Napte is a seasoned pharmaceutical professional with over 20 years of experience across Analytical Research, QC, and CROs. He is the founder of Pharma Growth Hub, delivering over 450 online sessions on topics such as ICH guidelines, QMS, Drug regulation, and method development & validation. Bhaskar is committed to empowering professionals to excel in their careers.
