Introduction to Process Validation
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.
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
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.
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