Course Description

Introduction to Process Validation

Course Description:

This preparatory course provides a hands-on overview of manufacturing process validation for medical devices and lays out the key principles of process validation including the regulatory requirements calling for process validation. 


The basic statistical considerations for process validation are presented clearly through a simple example.


The course will familiarize the learner with:

  • What is process validation?
  • What is verification?
  • When must process validation take place in lieu of verification?
  • Regulatory expectations
  • The concept of “variation”
  • The concept of “process capability”
  • Process inputs
  • General requirements for process validation
  • The three phases of process validation
  • European regulatory requirements for process validation
  • US regulatory requirements for process validation
  • Planning and outputs related to process validation
  • Contribution of risk management to process validation

A brief section showing warning letters from the US FDA addressing findings related to process validation completes

this overiew course.


Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

  • Comprehend the regulatory framework relating to process validation in the manufacturing of medical devices
  • Participate and contribute to your organization’s process validation activities
  • Evaluate the needs for process validation in your organization

Who Should Enroll:

Development and manufacturing engineers and staff new to medical devices. Supply chain and purchasing managers and associates that are involved in supplier audits. Regulatory and quality associates needing an introduction to process validation. Executive management who wish to oversee compliance-related aspects of process validation for medical devices.


Prerequisite Knowledge/Requirements:

Participants should have a basic understanding of the knowledge areas covered within the following WMDO training courses:

  • ID 77 – Risk Management for Medical Devices in EU and US (3-course suite)
  • ID 183 – The design, development and industrialization of medical devices
  • ID 196 – ISO 13485: Foundation and basic principles
  • ID 185 – Importance of technical standards in the medical device sector

Subject Matter Expert:
Steve Marshall

Duration:
75 min

Release date:
04/23/2012

Related resources:
Yes

Case studies:
No

Peer review:
Michael Maier

Price:
Basic Account: € 221.00
Premium Account: € 166.00

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