Get 50% off with the coupon code COUPON50Validation of Analytical Methods
- Tuesday
- June
- 17
- 2025
Dr. Ganesh Prasad Overview
Key analytical methods will need to be validated in order to ensure that the method is accurate, reliable and consistent. i.e. demonstrate fitness for the purpose. The lecture will discuss various aspects of method validation with reference to chromatographic methods as a specific case. Prerequisites of validation, like, qualification of Instruments, selection of various validation parameters, defining acceptance criteria and preparation of a validation protocol will be discussed. Procedure for method transfer to QC lab will also be discussed.
Why you should Attend
Key analytical methods used to assess quality of pharmaceutical products requires validation. Quite often confusion exists among analysts & executives regarding the extent to which test methods should be validated and coverage of various validation parameters. This lecture provides an understanding of how to plan and execute a key test method validation.
Areas Covered in the Session
- Which methods require validation
- Instrument qualification
- System suitability criteria
- Validation parameters
- Specificity
- Precision (repeatability, intermediate precision& reproducibility)
- Accuracy
- Linearity
- Robustness; Method transfer
- Validation Protocol & Report
Who Will Benefit
- QC Analysts
- QA Chemists and R&D and Analytical R&D Chemists
- Personnel from Tech Transfer
Speaker Profile
Dr. Ganesh Prasad is a freelance Pharma consultant in India under the banner ‘Q_Pharma consulting India & holds a doctorate degree in Organic Chemistry from Indian Institute of Science, Bengaluru. Previously, he worked at senior levels in pharmaceutical companies like Apotex Pharmachem India Pvt Ltd, ICI Pharmaceuticals, India and other organisations heading QA/QC/Process functions. He has also worked as scientist in the US FDA laboratory in Washington and other reputed institutions in USA/ Canada/India. He has together more than 30 years of experience together in quality assurance function, research in academia and industry. As a consultant he has assisted many pharmaceutical companies towards establishing cGMP standards of US FDA, European and Indian regulatory agencies. He also conducts third party quality audits of pharmaceutical manufacturers. He has conducted many public and in-house workshops and delivered invited lectures in forums like UBM, ISPE, DIA and so on.