How to identify an OUTLIER during an OOS Investigation?

#outlier #pharma #oos #interview
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1. Assay method validation mastery
» Everything you need to know perform assay validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements
2. Dissolution method validation mastery
» Everything you need to know perform dissolution validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements
3. Related substances method validation mastery
» Everything you need to know perform RS validation
» Preparation of conc. matrix, protocol, calculations, report wrt global requirements
4. Residual Solvents method validation mastery
» Everything you need to know 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
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6. Stability Study Mastery
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» 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
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» 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
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11. ICH Quality Blueprint
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12. FDA 483 Observations
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13. Impurity Management blueprint
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» Limit for residual solvents
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14. Instrument Calibration Mastery
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15. Instrument Qualification mastery
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» Calibration templates & formats
16. Information Technology Blueprint
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» Specification for unknown impurity
» Specification for known impurity
18. Pharma tech blueprint
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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
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23. Interview Question Model
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24. Job Search Strategy
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» Job search tracker
» How to connect with TAMs
» How to communicate with TAM
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» LinkedIn optimization
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» Job interview checklist
» Job INTERVIEW questions
» Phrases to avoid
» Power of words
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[@bulusuni]

Excellent

[@ahmaddina5527]

Interesting

[@LearnValue]

Very good

[@LearnValue]

Make video on microbiological assay

[@LearnValue]

Is it necessary to find outlier?

[@shravangattu5783]

Thank you 🙏

[@saradaverans]

Thanks sir