Course Content
QA introduction
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QA introduction
Good Manufacturing Practices (GMP)
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Introduction
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Personnel
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Premises, Sanitation & Hygiene
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Practices, Equipment, Materials
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Contracts production & analysis, Internal audits, Product quality review, Documentation, Complaints.
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Summary
Equipment Qualification
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Introduction & machine life cycle steps
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V model (Left and base parts)
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V model (right part) & Documentation & Re-qualification
In process control
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In process control (IPC)
Internal audit
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Introduction
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Audit definition and steps (Planning 1)
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Audit steps (Planning 2)
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Audit steps (Implementation 1)
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Audit steps (Implementation 2)
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Audit steps (Implementation 3)
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Audit steps (Conclusion & Follow up) & revision
Deviation management (CAPA)
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Introduction
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Deviation Identification
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Deviation evaluation, classification
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Investigation and route cause analysis
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Action plan
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Follow up, closing & Documentation
Change Management
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Change Management 1
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Change Management 2
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QA role in change management & Difference between change and deviation
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Change management example
Employees Qualification
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Introduction
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Job Requirements & Job Descriptions
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Training
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On job training
Process Validation
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Process Validation
Documentation
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Documentation (GDP) intro
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Documents 1
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Document 2
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Good Documentation practices 1
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Good Documentation practices 2
Student Ratings & Reviews
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Lessons:
