Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are articles addressing an issue that became a headline topic during the pandemic—and one that the industry continues to address: drug shortages and the supply chain. There are many questions about these issues: these articles present some strategies for addressing the challenges.

What is the current state of your organization’s Change Management (CM) System? The effective management of change throughout the product lifecycle enables quality improvement and is critical to patient safety, supply reliability, as well as operational effectiveness and efficiency.

The 2022 Planning Committee is delighted to welcome attendance and registration for the fast-approaching ISPE Biotechnology Conference, taking place 28-30 June in Boston, Massachusetts and virtually.

The life sciences industry is in the middle of a significant construction boom, partly fueled by research and manufacturing of vaccines and therapies to fight the COVID-19 virus and its variants. There are hundreds of new projects under construction, in various stages of planning or just completed. The developments run the gamut from production facilities to office space to laboratories for...

Microbial quality encompasses sterility assurance—and more, as discussed by Joyce Hansen, Vice President of J&J Microbiological Quality and Sterility Assurance at Johnson & Johnson in the keynote at the Plenary Session, “Microbiology Quality and Cultivating Emerging Leaders” that kicked off Day 2 of the 2022 ISPE Aseptic Conference.

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from February 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

The 2022 ISPE Aseptic Conference opened on Monday 14 March with keynote presentations by two regulators focusing respectively on PIC/S harmonization efforts (including the forthcoming Annex 1 revision) and FDA...

This article describes an amazing story of self-sufficiency: how Thailand has managed to develop six different Covid 19 vaccines in a very short time. This story describes how the Thai Government, The Royal Family, the Universities and private companies are working together to benefit the nation, three of these are using new technology developed in Thailand.

Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are articles from 10 years ago: the year was 2012, and ISPE members were reading about a holistic approach to pharmaceutical manufacturing, defining metrics and intelligence, battling counterfeit medicines, and more.

The very definition of gratitude seems lovely – be thankful, show appreciation and return kindness.

Every year, the world rallies together on March 8th in support of International Women’s Day. This year, the movement is diving into the importance of creating a world free of bias, stereotypes, and discrimination. Below, two members of ISPE’s Women in Pharma Steering Committee share their perspective on biases, and how they navigated these experiences throughout their careers:

Fatima Jacoba Mancilla Islas is a Foundation Board Member of the ISPE Mexico Affiliate and is currently a Validation Manager for Probiomed SA de...

The Women in Pharma Steering Committee Discuss Biases for International Women’s Day

Looking back on my career, I can honestly say, with a genuine smile, that, I am completely satisfied. I want for nothing, and for that I am overwhelmingly grateful and incredibly proud.

The COVID-19 pandemic has significantly disrupted the biopharma industry megatrends and the world in ways that could not have been predicted. As a result, it forced world leaders, global economists, innovators, and suppliers to collaborate, rethink outdated processes, and innovate together to combat the virus for one common goal, to save human lives. It was by far a pinnacle moment and a great...

A panel of regulators representing BfArm, Germany; the Therapeutic Goods Administration, Australia; and the US FDA took place at the 2021 ISPE Biotechnology Conference and Workshop. The...

Featured in this edition of iSpeak Reading Roundup, are the top blog posts from January 2022. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.

In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Lynda Goldbach, Manager of Publications, Publications Department.

Oxana Pryanichnikova is the Vice-Chair of ISPE Eurasian Affiliate with intensive involvement in the foundation of local ISPE organization since 2018. She is the Chief Business and Operating Officer of DXDO with more than 20 years in Software and Hardware Sales, Track&Trace projects, Business Development, planning and executing...