13 – 14 April 2026: Medical Device Manufacturing Process Validation

Medical Device Manufacturing Process Validation

DATE:  13 & 14 April 2026

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

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