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Process Validation for Medical Devices

Picto Training Process Validation for Medical DevicesUse a Recognized Method, GHTF Guidelines

Course Objectives

This program is designed to provide participants with a variety of knowledge and skills:

  • Understand the specific regulatory requirements for process validation in Europe and the United States
  • Understand the purpose of validation
  • Implement the validation method recommended by the GHFT guidelines
  • Use quality tools and statistical methods in the context of process validation

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combo ISO 13485 9001

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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

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Santa Clara, CA