
Medical Device Manufacturing Process Validation
DATE: 9-10 July 2025
TIME: 9.00am – 5.15pm
VENUE: Ascott Gurney Hotel, Penang
DURATION: 2 full-day course
COURSE OBJECTIVES
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.
COURSE OUTLINE
- Validation – ISO and Regulatory Requirements
- Validation Master Plan
- Risk Assessment in Process Validation
- Statistical Tools and Techniques
- Validation System
- Process Validation
- Software Validation
- Equipment/Process/Software Qualification
- Change Control
- Benefits of Validation
COURSE FEES (8% SST included)
Early Bird Price (until 18 June 2025)
Member: RM 1,998.00
Public: RM 2,214.00
Normal Price (from 19 June 2025 onwards)
Member: RM 2,214.00
Public: RM 2,430.00
CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: admin@medsociate.com
Tel: +6012 539 4194