Kiến Thức Cơ Bản về Xác Nhận Quy Trình IQOQPQ cho Thiết Bị Y Tế

Process Validation of Class 1/2/3 Medical Devices shall meet ISO 13485 standard and FDA 21CFR 820.75 requirements.

The objective of the course is to provide the course audience with the tools and knowledge to use the Process development, Quality principles and Program management to perform their Process Validation activities to meet regulatory, compliance and customer requirements.

It is a vast subject completely based on YOUR products, medical device class, team size, manufacturing method etc.

The course is explained with various phases and links to make a New Product Launch Validation successful.

A Designer doesn't get a manufacturing perspective, a Process Engineer doesn't understand a QE and QC lab perspective, the Instructor covered all those important bases to make this course holistic to manage and be successful.

This course will teach you cross collaboration activities involved in Process Validations from Engineering responsibility to Quality to Operations.

This is a high collaboration work with various hand offs between various functions in your organization, but once trained on the overall process, you will be ready to start. The first 2 product launches will help you identify the processes and the bottlenecks within, and when you are ready to launch your third product, your team's maturity on the process will help a lot to successfully & smoothly do your Process Validation.

The standards and FDA requirements have a lot of room for interpretation, the Instructor has taken his best diligence to provide guidance through this  course. At the end of this course, you will have been provided with an overview of the Process Validation regulatory requirements and what you need to perform them without any bottlenecks in your organization.

A very good luck on this journey.