Process Validation for Medical Devices

Process Validation for Medical Devices

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

Course Highlight:

  • Overview of the Process Validation
  • Types of the Process Validation
  • What is Validation Master Plan (VMP)?
  • What is Design Qualification? FAT? SAT? 
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Validation Report (VR)
  • Monitoring and Review of the Process Validation
  • When to perform the re-validation? 
Useful template (VMP, VP, IQ, OQ, PQ, VR) would be provided as case study to carry out the practical activities. 

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.

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Process Validation for Medical Devices

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