Plastic Process Validation

Course Developer has trained nearly 700 FDA Investigators!

Process Validation makes good business sense

This course was developed by James Ladtkow. He has trained nearly 700 FDA investigators in the area of "medical devices and plastic processes." This course discusses Process Validation elements and concepts that are not only consistent with FDA compliance, but also make good business sense.

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.

Topics covered include:
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