Calculation of an Unknown Impurity in the Combination Drug Product

#impurity #interview #pharma
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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
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» 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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