…to bond to substrates like PE and PP, surface preparation can improve the adhesion. Chemical primers, corona treatment, or plasma treatment (preferably with oxygen gas) are very commonly explored, as…
…to bond to substrates like PE and PP, surface preparation can improve the adhesion. Chemical primers, corona treatment, or plasma treatment (preferably with oxygen gas) are very commonly explored, as…
…pipe dream. Important dates for compliance The following dates are immensely important when it comes to UDI compliance for Q4-2013 and beyond. For starters, December 18th is extremely important. It…
…pipe dream. Important dates for compliance The following dates are immensely important when it comes to UDI compliance for Q4-2013 and beyond. For starters, December 18th is extremely important. It…
…new position. Of all the areas identified, finding engineers to support this new role is the most challenging for most organizations. Effective systems engineers embody strong cross functional and interactive…
…new position. Of all the areas identified, finding engineers to support this new role is the most challenging for most organizations. Effective systems engineers embody strong cross functional and interactive…
…expect to see the audit schedule and evidence of compliance. The evidence of compliance can be in the form of the presenting the audit plan, agenda, and signed interview sheet….
…expect to see the audit schedule and evidence of compliance. The evidence of compliance can be in the form of the presenting the audit plan, agenda, and signed interview sheet….
…Part 11 compliant. Finally, any system designed to meet the intent of Part 11 compliance must be properly validated. The purpose of the validation is to ensure: Any changes made…
…Part 11 compliant. Finally, any system designed to meet the intent of Part 11 compliance must be properly validated. The purpose of the validation is to ensure: Any changes made…
…oversight is a given. Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit…
…oversight is a given. Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit…
…Physical inventory Count Sheets. Also, the count sheet indicated Bin (b)(4) contained (b)(4) units of Crown 3 (Part 836-028, Lot I1CDC) however; this component was not present in the bin….
…Physical inventory Count Sheets. Also, the count sheet indicated Bin (b)(4) contained (b)(4) units of Crown 3 (Part 836-028, Lot I1CDC) however; this component was not present in the bin….
…“widget” example. The widget is assembled, placed into a pouch, the pouch sealed, and the batch sterilized and released. Customers are complaining that some pouches are open upon receipt. As…
…“widget” example. The widget is assembled, placed into a pouch, the pouch sealed, and the batch sterilized and released. Customers are complaining that some pouches are open upon receipt. As…
…of compliance. Four – If calibration is performed on-site, make sure metrology contractors are trained to applicable SOPs and the training is documented; a.k.a. documented evidence of compliance. In closing,…
…of compliance. Four – If calibration is performed on-site, make sure metrology contractors are trained to applicable SOPs and the training is documented; a.k.a. documented evidence of compliance. In closing,…
…Compliance with ISO 14644-1); and ISO 14644-3:2005 (Clean Rooms and Associated Controlled Environments – Part 3: Test Methods). If your organization employs compressed air, then ISO 8573-1:2010 (Compressed Air –…
…Compliance with ISO 14644-1); and ISO 14644-3:2005 (Clean Rooms and Associated Controlled Environments – Part 3: Test Methods). If your organization employs compressed air, then ISO 8573-1:2010 (Compressed Air –…
