What is Method Validation? How to perform Method Validation?
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- Опубликовано: 30 июл 2024
- #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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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
Bhaskar sir very good topic you have discussed very precisely.
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 💙
Thanku so much sir for providing a great knowledge of AMV
This was a great review for me as I am currently job searching after a 5 month break. Thank you.
Thank you sir... given useful information
Very well explained...thank you sir
Thank you very much for your videos ☺️☺️☺️ sir
thanks sir for your valuable guidance , very few peoples in pharma industry gives such a guidance , thanks a lot
True words
Excellent video sir 👏👏👏
Thank you sir,...
Thank you so much sir 🙏🤩😍
Great work sir....
It’s very helpful 😊
Thank you very much Sir
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?
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.
Thanks a lot sir
Sir, could u please,explain how to set peak purity parameter in agilent
Sir from where we take the acceptance criteria for the parameters?
Specificity selectivity same or different
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! 😊
Aaaaaaaaaaaaaaaaaa
If 150mg/day MDD then what is impurities limit.
Great content
Thanks sir
You have the best knowledge on what your teaching boss
Thanks, but, believe me, I am also learning while teaching. I may not have the best knowledge, but I do have the right intentions :-)
You know all.
Pls keep a session on GC method development
👏👏👏👏👏👏👏thank you
Why accuracy performed in 3set sir?
Too good
Give recovery calculations with example
Tq sir
Very clear explanation
Quality
Sir why 6 sets are choosen for reproducibility..??
Hi Yogesh here
Thank you Sir