Process Validation for Medical Devices

Category: Medical Devices QMS Related Training

ISO 13485

Medical Devices

Regulatory Requirement

US FDA

Validation

Description
Inquiry

Course Objective:

General requirements for Process Validation
The linkage of the Process Validation with the standards and regulatory requirements
Step-by-step on performing the Process Validation
Hands on experience to develop Process Validation documentation

Duration:

2 days

Suitable for:

This course is designed for the employees from all the function/levels whom would like to gain understanding on the Process Validation requirements, including those from the organizations that are currently certified to ISO 13485:2016 or yet to certified. This course is particularly essential for those direct involve in the medical device design & development and manufacturing process setup personnel.