Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme

Medical Device Manufacturing Process Validation


The global medical device market is governed by various quality system requirements and regulations of different countries. Medical device manufacturers need to perform process validation in order to comply with regulatory requirements and ensure business success



This course provides regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.


  1. Regulatory/QMS Compliance

1.1. QSR-21 CFR Part 820/ 21 CFR Part 11                                                  

1.2. ISO 13485:2016, GHTF/SG3/N99-10:2004 (Edition 2)


  1. A Brief Introduction to Validation System

2.1. Process Validation/Software Validation System/Analytical Method Validation System

2.2  Cleaning Validation System/Packaging Validation/Sterilization Validation          


  1. Introduction to Process Validation

3.1. Overall Validation Program Description                                                 

3.2. Validation Definition                                                                                

3.3 Process Validation Decision Tree                               

3.4. Types of Validation                                                                                                

3.4.1. Prospective Validation/ Concurrent Validation                                                                         

3.4.2 Retrospective Validation/Revalidation


  1. Validation Master Plan

4.1. Life Cycle Approach in Process Validation                                            

4.2. Risk Assessment in Process Validation

Medical Device Manufacturing Process Validation


  1. Elements of Process Validation System

5.1. Installation Qualification (IQ)/Operational Qualification (OQ)/Performance

Qualification (PQ)

5.2. Maintaining State of Validation                                                                         

5.3. Deviation in Process Validation           

5.4. Change Control in Process Validation                                                


  1. Statistical Tools & Techniques

6.1. Acceptance Sampling Plan                                                                    

6.2. Measurement System Analysis                                                                         

6.3. The 7 Basic QC Tools                                                                              

6.4. Process Capability Analysis                                                               

6.5. Statistical Method and Data Analysis


  1. Validation- Benefits and Good Documentation Practice

7.1. Good Validation Documentation Practice                                                             

7.2. Benefits of Process Validation



Two (2) full days



Remote Online Training or Classroom Training



Knowledge of medical device manufacturing and preferably an understanding of Quality Assurance or Quality Management System or Good Manufacturing Practices.




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