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This 6-hr training provides a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. Information includes preparation of protocols and reports, application of Statistical Process Control, concepts of Design of Experiments, using attribute sampling plans, and a discussion of GHTF document on process validation.

Why Should You Attend:

In your manufacturing processes, how can you be sure the output is right if you don’t check every piece? Many manufacturers face this problem, but don’t always have a good solution. The FDA expects you to answer it using process validation. Using the Quality System Inspection Technique (QSIT) the Inspector will ask for process validation procedures and the results for your product. Product, as defined by QSR includes components, in-process devices, and finished devices.

Do you know which processes in your firm require process validation? Can you provide objective evidence that you evaluated each process and documented the decision?

With the FDA looking closely, can you show how the product requirements moved from design through Design Transfer to Production? Can you show that you validated and monitor the production processes? The lack of procedures and data can lead straight to 483s, warning letters, and even product seizures.

Learning Objectives:

Sign up your entire team and get a clear understanding of the requirements and methods for process validation, including:

Understanding what “a high degree of assurance” means in statistical terms.
The three step approach employing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Developing protocols and reports for IQ, OQ, and PQ.
What information to include in the protocols and reports.
How to use the link the IQ Protocol to OSHA requirements to enhance your total regulatory compliance.
The basics of Statistical Process Control (SPC) to help monitor the validated process.
The role of Design of Experiments (DOE) to help define acceptable process parameters and develop challenge points.
Using attribute sampling plans in process verification.
The FDA Guidance document on process validation and the current status from the CDRH view.
The Global Harmonization Task Force (GHTF) document on process validation.

Who Will Benefit:

Process validation starts with design controls and moves to manufacturing through design transfer
Design Engineers
Design Technicians
Production sets and monitors the process parameters to make the product
Quality Engineers
Production Engineers
Production Managers and Supervisors
Production Operators

Official Website:

Added by complianceonlinecom on November 7, 2012