AMMI organised the training on Medical Device Process Validation Training at G Hotel Gurney from 23-24 November 2017. Forty seven (47) participants from twelve (12) companies attended the training which was conducted by industry expert, Mr Gobu Devarajan. The course 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. |