List of Contributions

Hi All What is the FDA requirement for reuse the pure water coming out from a super-Heated sterilization (121 °C)system  in a Pharmaceutical facility manufacturing IV Bag and how many times can we use before replace that water, is it every 8 hours shift or per day or per batch ------------------------------ ...

Hi All,  Our company is about to start a new project to manufacturing IV bag making, Filling and sealing , could anyone advise what is the regulation to control this process and FDA requirements  Thanks ------------------------------ YASSER ESTAFANOUS Chief ofQuality & Regulatory officer Winter ...

Hi All, if anyone has a template for the PSUR report for Medical device, please share it with me  Thanks ------------------------------ YASSER ESTAFANOUS Director of RA/QA Winter Haven FL United States ------------------------------

Hi everyone we are located in the states, we are marketing an IIa medical device( under the name of B)  in US and Canada this device is manufacturing and design in China ( device name is A) and we need to expand our marketing in EU , the manufacturer already got the EC certificate for the device(A ) ...

Thanks, Micheal,That's so helpful