Learning objectives
After completion of the course, you will be able to work in QA department with adequate knowledge and good subject understanding.
Eligibility
B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their Quality Assurance knowledge
Anyone willing to understand this topic can enroll.
Syllabus
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Section 1: Departments in pharmaceutical industry & responsibilities
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- Depts and responsibilities 30 minutes
- Section 2: Organogram & its advantage
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- Organogram & its advantage
- Section 3: Job descriptions of QA functions
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- Job descriptions of QA functions
- Section 4: Introduction to ICH and ICH Quality guidelines
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- Introduction to ICH & Quality guidelines 100 minutes
- Section 5: Process flow: receipt of material to dispatch of final product
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- Process flow: receipt of material to dispatch of final product 35 minutes
- Section 6: Process flow of API and formulation manufacturing
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- Manufacturing process flow of API 60 minutes
- Manufacturing Process flow: Formulation 75 minutes
- Section 7: How to write SOP & List of key QA SOPs
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- SOPs 28 minutes
- Annexure II
- Section 8: Good Documentation Practices, Document management system
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- Good Documentation Practises, Document management system
- Annexure I
- Annexure II
- Annexure III
- Section 9: Documents and records generated by QA and their applications
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- Documents and records
- Section 10: Specifications, Certificate of analysis
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- Specifications, Certificate of analysis 23 minutes
- Specifications Annexure I - IV
- COA Annexure
- Section 11: Data integrity
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- Data integrity
- Section 12: Vendor/supplier approval
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- Vendor approval
- Annexure
- Section 13: Change control
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- Change control 25 minutes
- Change Control Example 30 minutes
- Section 14: Deviations
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- Deviations
- Annexure III
- Section 15: Validation & qualification, Introduction to process validation, cleaning validation & Analytical method validation
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- Validation 1 hour 26 minutes
- Section 16: Internal audit (self-inspection)
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- Internal audit
- Internal Audit example
- Section 17: Regulatory audits
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- Regulatory Inspections
- Questions on all sections