ARMI | BioFabUSA will be offering a members-only series of technical workshops centered on advanced manufacturing technologies for Tissue Engineered Medical Products (TEMPs). In this exciting workshop series, you will hear from ARMI|BioFabUSA and its community members about the latest advancements in equipment, measurement, materials, and processes toward achieving scalable, modular, automated, and closed manufacturing for […]

By Derek Collins with contributions by Sylvan Poeckh Summary: Steam quality testing is performed to test the steam for Non- Condensable Gases, Superheat and Dryness. This paper will discuss what steam quality testing is, why it is required, where the sample ports should be located and when the testing should be performed of the test […]

On Friday, October 30, 2020 Boston University Questrom School of Business is hosting its 8th Annual Health & Life Sciences Conference. The theme of this year’s conference is “Healthcare 2025: Staying Ahead of the Curve,” and will explore how healthcare stakeholders are responding to challenges, access, and coverage disparities. This is an all-day, virtual conference […]

By: Howard Sneider Completing an investigation is one of the most strenuous responsibilities of individuals that work in quality system compliance. The investigation usually includes an investigative report to document the events and analysis of the proceedings. The investigative report is, with few exceptions, an irrevocable account of what has occurred and will largely determine […]

This summer is shaping up to be unlike any that I have ever experienced. Limitations on travel and activities because of COVID-19 will require individuals and families to be creative in summertime activities. Therefore when my wife suggested we invest in a 5000 gal swimming pool for the summer I figured, “why not?” I was […]

While it’s been a mild winter here in New England, winter weather is in the forecast for this weekend. When winter snowstorms hit, it’s a good idea to make sure that your laboratory is prepared to handle the consequences of inclement weather. As many of us know, snowstorms can result in power and WiFi outages. […]

At the recent GAMP Forum sponsored by the ISPE Boston Area Chapter, multiple presenters from across the US, all active members of the ISPE GAMP Community of Practice (COP), met  to discuss computer system validation (CSV) or Computer Software Assurance (CSA). First, a bit of background: As the regulated medical device and drug industry struggles […]

FDA continues to encourage the use of innovative new technologies to support the development of quality new drugs and ensure that patient safety is uppermost in the development and manufacture of drugs. As Scott Gottleib noted when discussing medical devices, FDA wishes to encourage device manufacturers to “make investments to re-tool their manufacturing processes” to […]