Description
Analytical Method Validation – Foundation Course
Course Description
This foundation course provides a clear and practical introduction to analytical method validation in the pharmaceutical industry. It explains how analytical methods used in drug development and quality control are scientifically proven to be reliable, accurate, and fit for their intended purpose.
Participants will learn the essential principles of method validation as per global regulatory expectations, including ICH guidelines, and understand how validated methods ensure data integrity, product quality, and patient safety throughout the drug lifecycle.
Key Learning Outcomes (Brief)
By the end of this course, participants will be able to:
- Understand the concept and importance of analytical method validation
- Learn key validation parameters: accuracy, precision, specificity, linearity, robustness, and range
- Understand regulatory requirements (ICH Q2 and GMP expectations)
- Differentiate between method development and method validation
- Learn basic validation protocol design and execution steps
- Understand system suitability and acceptance criteria
- Gain awareness of common validation challenges and troubleshooting approaches
- Interpret validation results and prepare basic validation reports
Course Outcome
Participants will gain a strong foundation in validating analytical methods, enabling them to support reliable testing, regulatory compliance, and quality decision-making in pharmaceutical development and manufacturing.
Target Audience
- Analytical R&D Scientists
- Quality Control (QC) Analysts
- Quality Assurance (QA) Professionals
- Formulation Development Scientists
- Regulatory Affairs Professionals
- Pharmacy and Life Sciences students
Course Outcome
After completing this course, participants will be able to design, execute, and interpret photostability studies in compliance with ICH guidelines, ensuring robust product stability, appropriate packaging selection, and regulatory approval readiness.
Sessions: 2 sessions (3 hours / 180 minutes each)
Mode of Training: Online (via Google Meet)
Certificate: Yes, certificate of completion will be provided
Money-Back Guarantee: 30-day money-back guarantee
Language: English
Instructor: Dr. Pramod Kumar Pandey (PhD in Chemistry) 31+ years of experience in global and Indian pharmaceutical industries
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