365° GMP Inspection & Audit Readiness
A practical, year-round GMP inspection and audit readiness training program.
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Course Content
Module 1: Course Introduction
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1. Course IntroductionLocked
Module 2: Fundamentals of Inspection and Audit Readiness
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1. Understanding GMP Inspections and AuditsLocked
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2. The 365-Degree Inspection Readiness ConceptLocked
Module 3: Quality System and Documentation Readiness
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1. Preparing the Pharmaceutical Quality SystemLocked
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2. Documentation and Data ReadinessLocked
Module 4: Facility, Equipment and Operational Readiness
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1. Facility Inspection ReadinessLocked
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2. Equipment, Utilities and Validation ReadinessLocked
Module 5: Personnel and Inspection Conduct
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1. Preparing Employees for an InspectionLocked
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2. Managing Inspector InteractionsLocked
Module 6: Finding Gaps Before the Inspector Does
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1. Self Inspection and Readiness AssessmentsLocked
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2. Mock Regulatory InspectionsLocked
Module 7: Inspection Findings, CAPA and Sustained Readiness
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1. Managing Inspection ObservationsLocked
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2. CAPA Remediation and Maintaining 365-Degree ReadinessLocked
Module 8: Practical Tools and Templates
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1. Practical Tools and TemplatesLocked
Module 9: Practical Exercise and Completion
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1. Practical Exercise and CompletionLocked
Module 10: Key Learning and Closing
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1. Key Learning and ClosingLocked