Module -1
Cultural Paradigms: Transitioning from the Gray Market to Regulated Systems
Learning Journey
Introductory Phase – Cultural and Legal Restructuring
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Phase 0 – Foundational Alignment
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Phase 1 – Regulatory and Strategic Framework
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Phase 2 – Environmental & Infrastructural Context
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Phase 3 – Phylogenesis, Inputs and Active Cultivation
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Phase 4 – Harvest, Post-Harvest and Preservation
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Phase 5 – Storage & Quality Control
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- Module 10 – Storage & Intermediate Logistics: GDP Compliance and Physicochemical Stability
- Module 11 – Data Governance & ALCOA+: Metadata Structuring and Control
- Module 12 – Quality Management System (QMS): Architecture, KPIs, and Periodic Review
- Module 13 – Human Resources Management & Operational Training
- Module 14 – Analytical Testing, Method Validation & Batch Release
- Module 15 – Stability and Retest Strategies: ICH Protocols and Trending Analysis
Phase 6 – Occupational Safety & Preventive Controls
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- Module 16 – EHS & Waste Management: Regulatory Compliance and Risk Mitigation
- Module 17 – Risk Analysis & HACCP: CCP Identification and Deviation Management
- Module 18 – Internal Audit and Continuous Improvement: Methodology and Compliance Culture
- Submodule 18.1 – Strategic Value of Third-Party Audits
Phase 7 – Certification, External Audits and Market Access
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Phase 8 – Supplier Management & Digital Traceability
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Phase 9 – Continuous Compliance & Operational Optimization
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Phase 10 – National Adaptation & Commercial Strategy
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