What is Method Validation? How to perform Method Validation?

#pharma #pharmaceutical #interview #methodvalidation #

What is Method validation? How to perform Method Validation?

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Please find the main module details below...

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

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

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

*4. Residual Solvents method validation mastery*
» Everything you need to know to 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

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[gitoridaniel]

He is the best teacher I have seen in youtube, it was difficult to understand this analytical method validation I repeated many times now I get the right teach

[bubundatta]

Bhaskar sir very good topic you have discussed very precisely.

[titonsaha]

Thank you sir for your very clear concept. I have gone through several tutorials of Analytical Method Validation for getting a clear concept. Finally I have got the desired one, which I have been looking for a long since.

Thank you Again 💙

[achyutjagdhane]

thanks sir for your valuable guidance, very few peoples in pharma industry gives such a guidance , thanks a lot

[joicenteredwellnessasmr]

This was a great review for me as I am currently job searching after a 5 month break. Thank you.

[kairosworship]

You have the best knowledge on what your teaching boss

[dharmpalsharma]

Thanku so much sir for providing a great knowledge of AMV

[gille]

Dear Bhaskar, thank you so mucj for this video. It was explained in full details and it helped me a lot with the studying material I'm dealing atm. Maybe it would be a good idea to put the name of the methods somewhere in the corner of the video so when we skip the video forward or back (depending on what we need) to find it more easily. Thank you once again! 😊

[pradipmahajan]

Very knowldegabke explanation Sir, Thank you. Like to join and learn from Pharma Hub soon. At 20:00 while narrowing the range of pH you bymistakely increased the range from 4.2.

[vijaykumar-sowc]

Thank you sir... given useful information

[junimyerainfo]

Thank you very much for your videos ☺️☺️☺️ sir

[srirampmna]

Sir, could u please, explain how to set peak purity parameter in agilent

[krish_krish]

Specificity selectivity same or different

[swatidasgaonkar]

Pls keep a session on GC method development

[nitinsalunkhe]

Give recovery calculations with example

[bushraqamar]

In specificity parameter, when impurities are unavailable, ICH guideline said to use a second well characterized producer e.g. pharmacopeial method or other validation method. Can you please explain, when we have an other second well characterized method, than why we are doing this validation exercise on new one?

[yogeshmandole]

If 150mg/day MDD then what is impurities limit.

[rahulchadha]

Sir from where we take the acceptance criteria for the parameters?

[yashikadalora]

Sir why 6 sets are choosen for reproducibility..??