ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
PIC/s Annex 1, and the WHO Annex 2 for the manufacturing of sterile products took effect on 25 August 2023, and the time to attend the 2023 ISPE Pharma 4.0™ and Annex 1 Conference couldn’t be better. The Equipment Innovation and Annex 1 Implementation Track Co-leads Richard Denk and Matthew Gorton and the Emerging Leader Co-lead Pol Bonet invite you to join them for this exciting event in...
The pharmaceutical industry is constantly evolving, placing a significant emphasis on emerging technologies that facilitate quicker access of medications for patients globally. This unceasing drive for innovation and improvement has led the industry to embrace cutting-edge technologies like data analytics, machine learning, and artificial intelligence. These technologies are not just trends;...
With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents. With the co-leadership of Christian Wöelbeling, Executive Industry Advisor at Körber Pharma...
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Facility of the Year Award (FOYA) Winners in the Supply Chain category exemplify novel application of principles, systems, and management tools aimed at improving operational speed, robustness, and response. These could be applied to areas in which delivery to market impacts patients, technology amplifies supply...
As a mid-career employee, I’ve earned expertise in many areas but feel I still have much to learn. More importantly, I feel have much left to offer.
Danielle Gabrish is the Director of Clinical Biologics at AstraZeneca and the Chair of the ISPE Women in Pharma® group for ISPE’s Chesapeake Bay Chapter. She’s also a mom, mentor, and advocate for women and Emerging Leaders.
You may have already read through our Members Guide to ISPE’s 2023 Annual Meeting & Expo, which offers a high-level overview of all the conference highlights. Within this article, we’ll break down the various Women in Pharma® activities scheduled throughout the meeting. From an empowering self-defense class to a nostalgic...
Addressing the unmet healthcare & medical needs is among the top priorities for global governments and organisations, including the pharmaceutical industry. We are facing unprecedented challenges due to the change with medical knowledge doubling every 72 days1
Shanghai ISPE Pharmaceutical Information Company (SPIC) held the 2023 Global Biopharma Engineering Forum and ISPE China Conference in Hangzhou, China on 26-27, May 2023. Mr. Ping Zhang, Chairman of SPIC and the ISPE China Committee, introduced ISPE and provided an in-depth analysis of the prospects of domestic and foreign bio-pharmaceutical enterprises. The in-depth discussions from this...
Facility of the Year Award (FOYA) Winners in the Innovation category exemplify the application of novel manufacturing processes, innovative design concepts, new technologies, and unique solutions that...
Cloud-based systems for plant process management (PPM)1
Facility of the Year Award (FOYA) Winners in the Operations category exemplify the application of novel tools and approaches to delivering projects that improved efficiencies, overcame unusual challenges,...
Building off of the success of the 2022 ISPE Annual Meeting & Expo, the 2023 ISPE Annual Meeting & Expo Program Committee has developed a robust Workshop program covering key areas in Digital Transformation (DT) and Pharma 4.0™, Quality Risk Management (QRM), Contamination Control Strategy (CCS) and Annex 1, Facility...
Data Governance is currently utilized in many areas of business and government including finance, banking, telecommunications, and by the agencies regulating these industries. In pharmaceuticals, digital validation is still at a relatively early stage of the digital transformation journey where data governance is currently managed in silos of data (Industry 3.0) and the industry has of yet to...
Pharmaceutical Engineering® is delighted to announce the finalists for the 2022 Roger F. Sherwood Article of the Year Award. The articles were selected by judges of 36 feature and...
Opening the 2023 ISPE Europe Annual Conference on 8 May, Peter Twomey, Head of Inspections for the European Medicines Agency (EMA), offered a keynote address titled International Cooperation, Harmonization, and Reliance in GMP.
In the beautiful city of Barcelona, Spain, ISPE will host members, vendors, pharmaceutical companies, consulting firms, and design companies for the 2023 ISPE Pharma 4.0™ and Annex 1 Conference on...
Emer Cooke, Executive Director of the European Medicines Agency (EMA), delivered an impactful keynote address at the 2023 ISPE Europe Annual Conference, held 8-10 May , in Amsterdam, The Netherlands. Cooke...
