ELearning Library

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.

Plastics Process Validation

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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