HPLC Method Development 20 Nov 2022: Q&A Session 1

#hplc #methoddevelopment #interview #q&a

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Please find the main module details below...

*1. Assay method validation mastery*
» Everything you need to know perform assay validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements

*2. Dissolution method validation mastery*
» Everything you need to know perform dissolution validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements

*3. Related substances method validation mastery*
» Everything you need to know perform RS validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements

*4. Residual Solvents method validation mastery*
» Everything you need to know perform Res sol. validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements

*5. Extractables & Leachables Blueprint*
» What is E&L
» What is the source of E&L
» How to use Risk-based approach for safety assessment
» What are Thresholds for E&L
» How to design E&L Study

*6. Stability Study Mastery*
» Basic terms in stability study
» Stability study for submission
» Preparation of stability protocol, report
» IQ, OQ,PQ of stability chamber

*7. Method development blueprint*
» HPLC, GC, Dissolution, Spectroscopy Method Development

*8. Cleaning validation blueprint*
» How to perform cleaning validation

*9. Mutagenic & Nitrosamines*
» Understand regulatory aspects of mutagenic & nitrosamines
» Testing need of Mutagenic & Nitrosamine into your product
» LOQ requirement for Nitrosamine test procedure
» Limit for new Nitrosamine impurity
» Limit for mutagenic impurity

*10. QMS Mastery*
» Incident, OOS, OOT, CAPA, Change control
» QMS examples

*11. ICH Quality Blueprint*
» Comprehensive course on ICH Quality guidelines

*12. FDA 483 Observations*
» Comprehensive info on FDA 483 recd. By Indian Pharma (10-12 yrs)

*13. Impurity Management blueprint*
» Limit for known, unknown, total impurity
» Limit for residual solvents
» Release & Stability specification for Impurity

*14. Instrument Calibration Mastery*
» Calibration of common lab instrument
» Calibration templates & formats

*15. Instrument Qualification mastery*
» Qualification of common lab instruments
» Calibration templates & formats

*16. Information Technology Blueprint*
» Electronic data management
» Server Data Backup, Retrieval, and Verification
» Preparation, Execution & Review of CSV

*17. Specification design blueprint*
» Specification for API/Finished product
» Specification for unknown impurity
» Specification for known impurity

*18. Pharma tech blueprint*
» More than 90+ videos on various topics of QC, QA, AR&D

*19. Concentration matrix design mastery*
» Concentration matrix for method validation
» Confirmation on selected weighing and dilution details
» Mapping expected concentrations for API/Impurities

*20. Calculation formula design mastery*
» Reporting and rounding of analytical results
» Basic calculation functions in excel
» Basic calculation formulas in Analytical chemistry
» Preparation of automated calculation sheet

*21. Concentration design blueprint*
» Conc. Optimization for assay, RS, Dissolution, Residual solvent

*22. Lab Operation Blueprint*
» Basic Lab Set-Up Guidance

*23. Interview Question Model*
» Likely Interview Questions

*24. Job Search Strategy*
» 3 Month job search plan
» Job search tracker
» How to connect with TAMs
» How to communicate with TAM

*25. Resume & LinkedIn Blueprint*
» Resume optimization
» LinkedIn optimization
» Resume writing
» Converting resume templates

*26. Job interview blueprint*
» Job interview checklist
» Job INTERVIEW questions
» Phrases to avoid
» Power of words

*27. Inner circle calls*
» Previously recorded sessions
» Opportunity to network with PGH Stars

Alternate payment options(GPay/PhonePe): 9766383968
Call @9766383968 for more info

[esakkiammalsudhaesakkimuth]

Thank you for your great work!! Q & A session is very useful and impressive!!

[nikitaborade]

Sir please upload yesterday's video on gc method development and troubleshoot

[trendbizz]

Good evening sir
I have a question that
im having a combination of two drug product have same nano meter now im getting one unknown impurity peak in middle of two drug peaks, im doing dilute standard method so how i will calculate that unknown impurity with respect to which drug peak and that impurity is not in degeneration data, not in Drug +Excipient study, stability data not in placebo blank ? So how i will get to know that unknown peak belongs to which drug

[samadhan.p]

Sir, please release video on quality control instruments having involved UV, IR, KF, PH, SOR, Autotitrator

[pankajnagwani]

Very nice session sir although I was not participated but it is very informative session

[sunandavalvi]

sir how to make a dilutions of herbal extract for hplc

[abhishekjoshi]

how to decide gradient ration in related Substace method?

[pankajnagwani]

Sir i also have a question that before doing analysis in HPLC instrument what are the conditions or fact about which we should care to select the mp

[omarfaried]

Firstly, I would like to express my gratitude for your great efforts. I have a few questions, please:

Why is ethanol not used instead of methanol?

What is the benefit of a pore size of 120 angstroms or more or less in relation to the analyte I need to separate?

How can I determine the polarity of my analyte before starting chromatographic separation to have an idea of the order of separation?

What are the acceptance criteria for receiving a column with respect to the theoretical plate reference limit?

Why does absorbance vary with different mobile phases or columns for the same components at the same wavelength?

In the column regeneration process for normal phase chromatography, I use water in one step. Conversely, in reversed phase chromatography, heptane is sometimes used. Is this harmful to the silica?

Why might different mobile phases alter the separation order of analytes, even though the principle of separation is based solely on the polarity of the analytes and the stationary phase?

[abhishekjoshi]

How to choose or decide or change gratient ratio?

[EARTH_THAKUR]

I want to develop sodium hyaluronate method on hplc please guide