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.
Over 50 members attended the AMMI 30th Annual General Meeting and Q2 Meeting held at E&O Hotel Penang. The AGM saw the retirement of AMMI Secretary-General, Mr H.T Eow (Abbott).
The AMMI Executive Board was announced during the meeting, with the following line-up: Chairman – Mr Christophe Marque (Stereo), Vice-Chairman, Mr John Ward (Steripack) , Vice-Chairman , Mr Andy Lee (Johnson & Johnson), Secretary-General, Dato’ Dr Haminnuddin (Ideal Healthcare) and Treasurer, Mr Michel Van Crombrugge (Paramit). The following member representatives were also elected to the AMMI Board of Directors: Dr Yuma Konishi (Texchem), Mr Samuel Pooranakaran (Cochlear), Mr Dave Mitchell (Boston Scientific) and Mr André Holzhausen (B.Braun Medical Industries)
Members then proceeded with the Q2 Progress meeting, followed by a briefing on the New NCER Tax Incentives and NCER Talent Enhancement Programme (NTEP) by Mr Jaspher Loo from the Northern Corridor Implementation Authority (NCIA). After the meeting, guests adjourned for CEO Networking after the meeting.
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