30 November – 1 December 2026: Medical Device Manufacturing Process Validation

Medical Device Manufacturing Process Validation

DATE: 30 Nov & 1 Dec 2026

TIME: 9.00am – 5.15pm

TRAINING MODE:
Option 1: Iconic Marjorie Hotel, Penang
Option 2: Online (via Zoom)

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

COURSE OUTLINE
1. Validation – ISO and regulatory requirements
2. Validation master plan
3. Risk assessment in process validation
4. Statistical tools and techniques
5. Validation system
6. Process validation
7. Software validation
8. Equipment / Software – DQ/IQ/OQ and PQ
9. Change control
10. Validation – Good Documentation Practices