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Introduction
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GMP Introduction
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GMP - Meaning and Overview
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The Main Risks
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Why is GMP Important
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GMP Directives
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GMP Basic Requirements
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Quality Systems
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Quality System
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Principle and Overview
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Case Study
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Personnel
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Principle
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Key and qualified personnel
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Responsibility Distributions
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Staff Training and Hygiene
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Premises & Equipment: Production Areas
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Premises & Equipment: Production Areas
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Storage Area
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Quality Control and Ancillary Areas
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Equipment
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Documentation
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Principle
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Generation, Control and Types of Documentation
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Manufacturing Formula & Processing Instructions
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Production
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Principle
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Prevention of Cross Contamination in Production
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Starting Materials and Processing Operations
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Packaging Operations
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Quality Control
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Principle
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QC Tasks
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Technical Transfer of Testing Materials
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Complaints, Recalls & Auditing
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Complaints & Recalls
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Complaints
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Classification of Defects
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Recalls
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GMP Auditing
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Product Traceability
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Introduction to Product Traceability in Manufacturing
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Benefits of Traceability in Manufacturing
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Classification of Product Traceability Studies
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Critical Considerations for Traceability
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How to Conduct Effective Traceability Studies
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Improving Product Traceability Program
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Standard Operating Procedures (SOP)
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Introduction to SOP Development
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Content of an SOP
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Steps to Developing a Standard Operating Procedures
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Root Cause Analysis (RCA)
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History of RCA
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RCA Defined
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Approaches to RCA
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Tools for RCA
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Conducting Effective RCA
Preview - Good Manufacturing Practices (GMP)
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