21-22 August 2019: Medical Device Manufacturing Process Validation Training
Thirty five participants from fourteen companies attended the AMMI Industry Expert Training on Medical Device Process Validation Training held at G Hotel Gurney, Penang. The training session was conducted by Mr Gobu Devarajan.
The training provided 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.