Introduction to Process Validation
This preparatory course provides a hands-on review of manufacturing process validation for medical devices. It lays out the key principles of process validation, including regulatory requirements. The basic statistical considerations for process validation are clearly illustrated in an example.
This course covers the following topics:
- What is process validation?
- What is verification?
- When should 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
At the end of this course there is a brief slideshow of warning letters from the US FDA addressing findings related to process validation.
Watch the Course Trailer:
Upon successfully completing this course, trainees will be able to:
- Comprehend the regulatory framework relating to process validation in the manufacturing of medical devices
- Participate and contribute to process validation activities
- Evaluate the need for process validation within their organization
Development and manufacturing engineers and staff new to medical devices, supply chain and purchasing managers and associates involved in supplier audits, regulatory and quality associates needing an introduction to process validation, and executive management employees who wish to oversee compliance-related aspects of process validation are all welcome to participate in this course.
A basic understanding of the following courses is required:
- Risk Management for Medical Devices in EU and US (3-course series)
- The Design, Development and Industrialization of Medical Devices (ID 183) – Under construction
- ISO 13485: Foundation and Basic Principles (ID 196)
- Importance of Technical Standards in the Medical Device Sector (ID 185)