Plastics Process Validation

Title: Plastics Process Validation
Course Type: Self Paced
Estimated time to complete: 3 Hours
Price: $199.00

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Process Validation has become very important to the success and even survival of companies. Not only does Process Validation help produce a product that meets the regulatory requirements, it is a tool which can provide better products. It can help produce a safer, higher quality product in less time and at a lower cost.

Although this course can be beneficial to those outside the injection molding world, the examples are all specifically related to plastic processes.

Course Outline

• Why Validate?
• Corrective and Preventive Action
• Failure Mode, Effects and Criticality Analysis
• Global Harmonization Task Force
• Verification Versus Validation
• Basics of Validation
• Validation Teams
• Raw Material Incoming Acceptance
• Mechanics of Process Validation
• Installation Qualification
  
  • Cooling Systems
  • Drying
  • What About the Tool?
  • Case Study
  • First Article Inspection
  • Mold Cavities
• Operational Qualification
• Key Processing Parameters
• Design of Experiments
• Gage R & R Studies
• Functional Tests
• Performance Qualification
  • Ultrasonic Welding Operation Example
• Natural Variation
• Process Capability
• In-Process Inspection Sheet
• Setup Sheet
• Setup Log
• Process Controls
• Revalidation
• Review of Process Validation Steps
  • Master Validation Plan
• Examples of Various Protocols

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