Course Schedule date:
|Monday| |Tuesday| |Wednesday| |Thursday| |Friday| (8.0 PM to 10 PM; IST)
Module - 1
- Introduction
- What is Method Validation?
- Need for AMV
- Method classification and its corresponding validation requirement
- A brief discussion of different guidelines
- Validation parameters
- FAQS and doubt clearance
Module - 2
- How to design a strategy for effective analytical method Validation?
- What is the pre-validation work?
- Necessary components required to perform Analytical method validation
- How to decide the validation parameters?
- FAQs and doubt clearance
Module - 3
- How to design and write a method validation protocol?
- How to perform specificity?
- How to perform DL and QL?
- How to perform precision (System repeatability, method repeatability, intermediate precision and method reproducibility)?
- FAQs and doubt clearance
Module - 4
- How to perform linearity and range?
- How to calculate RRF?
- How to perform accuracy and recovery?
- How to perform stability of solution?
- How to perform robustness?
- FAQs and doubt clearance
Module - 5
- Activities after validation
- How to prepare report?
- Report approval process
- How to perform validation of the pharmacopoeias method?
- A Bird’s eye view on cross validation
- A Bird’s eye view on re-validation
- Case studies
- Top interviews questions and their answers
- Doubt clearance
Bonus
- How to apply QBD approach in AMV?
- How to validate the Pharmacopoeia Method?
- How to deal with variation in area response?
- How to deal with Ghost Peak?