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Quality_Assurance_and_Safety

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General_Quality_Assurance_and_Safety
Includes: Companies, Introduction, History
Analysis_and_Reporting
Includes: Adverse Event Reporting, Benchmarking, Bioburden, Cause Analysis, Control Charts, Data Analysis, Data Collection, Evaluation, FMEA, Hypothesis Testing, Loss Function, Metrics, Process Analysis, Statistics, Statistical Process Control, System Analysis

Quality_Assurance
Includes: Problem Solving, Quality Function Deployment (QFD) / House of Quality, Robust Design, TRIZ (The Theory of Inventive Problem Solving)

Quality_Management
Includes: Cost, Customer Satisfaction, Design Control, Good Manufacturing Practice (GMP), Process Analysis, Process Management, Supplier Management, Technical Tools

Quality_and_Safety_Regulations
Includes: FDA, Guidance Documents, Relevant Laws and Regulations, Workshops and Courses

Reliability
Includes: Academic Programs, Analysis, Demand Time, Demonstration Testing, Design Transfer, Downtime, Duty Cycling, Failure Rate, Growth, HASS (Highly Accelerated Stress Screen), Modeling, Parameters, Probablity Function, Redundancy, Repeatability, Restorability, Step Stress Testing, System Design

Risk_Analysis_and_Risk_Management
Includes: Introduction, Glossary, Applicable Standards and Regulations, Journals, Failure Mode and Effects Analysis (FMEA/FMECA), Hazard and Operability studies(HAZOP), Fault Tree Analysis (FTA), Event Tree Analysis, Probabilistic Risk Analysis (PRA), Root Cause Analysis, Modeling Techniques, Example Applications, Risk Research Programs/ Academic Centers

Safety
Includes: Biosafety, Chemical Safety, Electrical Safety, Patient Safety

Standards
Includes: Introduction, Organizations, Intenational Standards, ISO 14971 (Risk Management), ISO 9000

Tracking_and_Testing
Includes: Continuous Improvement, Quality Improvement, Process Capability, Simulated Use, Six Sigma, Testing


Quality Assurance and Safety section edited by


last updated on 12/15/2005 at 8:28:05.0 PM by 69.104.179.149
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