Thirty AMMI members joined an exclusive plant tour at Osram Kulim in the two–part AMMI Industry 4.0 Events held on 26 August. In the afternoon, over 50 members attended the Industry 4.0 Workshop at The Light Hotel . MPDV and Rockwell Automation provided con-current demo sessions for the attendees.
Thirteen participants attended the AMMI Industry Expert Training on Effective Complaint Handling held at G Hotel Penang. Trainer Frank Ried provided participants with an overview about handling of Medical Device Complaints, from receiving complaints, registration, classification, investigation, initiating and following up of corrective actions until reporting and closing of a complaint.
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.
Seventy three participants from twenty-five companies attended the AMMI Global Expert Sharing on “Sterile Medical Packaging: Regulations, Standards, Design & Development and Validations” by Mr Thierry Wagner from DuPont.
Forty six participants from thirteen companies attended the AMMI Industry Expert Training on Software Validation Requirements and Excel Spreadsheet Validation held at G Hotel Kelawai, Penang. The training session conducted by Mr Gobu Devarajan, explored the requirements for Software and Excel spreadsheets used in production or the quality system and case studies on how verification/validation can be accomplished.
