Selecting Your Off-site GMP BioPharma Storage Provider

Posted by Michael Davanzo
On February 19, 2021

Abstract Off-site storage of GMP biological and pharmaceutical products and medical devices is a critical resource for biopharmaceutical companies, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs) facing storage and overflow issues. There are many critical factors to consider when selecting an off-site GMP storage provider. Among the most crucial factors to […]

Single Use Technologies Webinar Kicks Off the New Year

Posted by Caren Jenkins
On February 4, 2021

The Boston Area Chapter hosted the first educational program of 2021 on January 21 – a webinar on Single Use Technology presented by Process Engineer Alejandro Kaiser moderated by Educational Program Committee Co-Chair Aaron Hubbell. Alejandro is a dynamic speaker able to take complex subjects considered “a bit dry” and transform them into engaging, informative […]

How the Ethnocultural Diversity & Inclusion Initiative Came to Be

Posted by Eric Felz
On January 27, 2021

Let’s be honest. Conversations about racial diversity, equity and inclusion are tough. Lots of times, they are challenging and uncomfortable. However, over the last several years, the need for these conversations has become increasingly evident. Particularly, over the past year, I have seen a great deal of tension around racial inequality with demonstrations and protests, some peaceful, focusing on the collaboration […]

A TEMPlate for the Future of Biomanufacturing

Posted by ISPE Boston
On January 13, 2021

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 […]

Steam Quality Testing – Introduction & Best Practices

Posted by ISPE Boston
On December 8, 2020

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 […]

BU Conference Targets Proactive Approaches to Healthcare

Posted by ISPE Boston
On October 15, 2020

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 […]

13 Tips for Writing Effective Quality System Investigative Reports

Posted by ISPE Boston
On September 24, 2020

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 […]

Industry Veterans Provide Career Insights

Posted by ISPE Boston
On August 19, 2020

Interested in advice from respected industry professionals on how to achieve your career goals and navigate unexpected career turns? Then we’re sure you tuned in for the Chapter’s first career development “fireside chat” when Haroon Hashmi of Ziopharm Oncology and Jane Rhodes of Verge Genomics settled in for a virtual Q & A with moderator […]

ISPE Releases Good Practice Guide: Critical Utilities GMP Compliance

Posted by ISPE Boston
On July 23, 2020

ISPE has announced the release of its latest guide, “ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It.” The Guide was cultivated by leading experts to help pharmaceutical organizations achieve and maintain their critical utility systems in a state of control, and then be able to […]

Perfection is the Enemy of Progress: Thoughts on Continuous Improvement.

Posted by Howard Sneider
On June 24, 2020

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 […]

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