Determination of LoD & LoQ
More than 1000+ pharma professionals have chosen Pharma Growth Hub as their career acceleration partner, now it’s your turn!
27 courses worth Rs. 1,16,690/- are available for just *Rs. 6990/-* This offer may not stay for long, so take action.
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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