Verification of Compendial Test Procedures

How to verify compendial test procedure...
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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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[@marumugaraja1287]

U r super sir.

[@manojmodi414]

Excellent presentation Sir

[@krishivisionjath]

Very useful info

[@manojmodi414]

Thank you very much Sir 🙏

[@hafizullah916]

very informative and absorbable

[@masterji5797]

Hi sir. Specificity test is aimed at the molecule of interest in a matrix. Is the same applicable to APIs of 100% purity?

[@bulusuni]

Good

[@snehalbikkad1588]

Please review ICH Q8R2 guideline

[@ragavendhiranchd6123]

Hi sir...I need one doubt monograph method already validated but in monograph they not mentioned solution stability so what ia the general solution stability for Standard and Mobile Phase

[@pankajbisht9028]

Sir can u explain the same topic in hindi