How to identify an OUTLIER during an OOS Investigation?

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Pharma Growth Hub

Pharma Growth Hub

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#outlier #pharma #oos #interview
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Please find the main module details below...
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
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8. Cleaning validation blueprint
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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
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10. QMS Mastery
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» QMS examples
11. ICH Quality Blueprint
» Comprehensive course on ICH Quality guidelines
12. FDA 483 Observations
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13. Impurity Management blueprint
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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
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» Server Data Backup, Retrieval, and Verification
» Preparation, Execution & Review of CSV
17. Specification design blueprint
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» 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
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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
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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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Пікірлер: 7
@LearnValue
@LearnValue Жыл бұрын
Very good
@bulusuni
@bulusuni Жыл бұрын
Excellent
@ahmaddina5527
@ahmaddina5527 Жыл бұрын
Interesting
@shravangattu5783
@shravangattu5783 Жыл бұрын
Thank you 🙏
@saradaverans
@saradaverans Жыл бұрын
Thanks sir
@LearnValue
@LearnValue Жыл бұрын
Make video on microbiological assay
@LearnValue
@LearnValue Жыл бұрын
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