The ISPE community is saddened by the passing of James (Jim) O'Brien, a founding member of ISPE and a luminary in the field of pharmaceutical engineering. Jim was a recognized expert in the design and engineering of pharmaceutical facilities, whose profound influence has shaped our industry. Read more about his lasting impact on the ISPE and pharmaceutical communities: https://bit.ly/4cpuhkG
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Guiding the pharmaceutical and medical device industries to successfully transition into the era of AI/ML and Pharma 4.0, the presenters will provide tangible insights derived from GAMP and quality perspectives to ensure product quality, patient safety and data integrity. This webinar, hosted by Tomos Williams, Taylor Chartier, Doug Shaw, Martin Heitmann, and Joanne Donald, FRQA, will build on the foundations presented in the first two webinars (a) concept phase and b) considerations on data sets and representativeness) by discussing the system engineering and training stages of AI/Ml subsystem development. Example studies and use cases will accompany this webinar to provide further practical insights. Register for this complimentary webinar: https://hubs.la/Q02GzZ8P0 ISPE webinars can be accessed on-the-go via the free ISPE mobile app, by selecting the "Menu" option: https://hubs.la/Q02GB1sH0 #ISPE #pharma #pharmawebinar #gamp #ai #ml #pharmaai #pharma40
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ISPE is conducting training events at the renowned European Aseptic and Sterile Environment (EASE) Facility in Strasbourg, France. These training events provide our most hands-on opportunities for attendees to interact with equipment. Don't miss your opportunity to conduct exercises in the classroom, as well as in the clean rooms at the EASE facility. September: • Commissioning & Qualification, Process Validation, and ATMP • Aseptic Processing & Annex 1 November: • Biopharmaceutical Manufacturing Facilities and Processes Training Learn More & Register: https://hubs.la/Q02GmWVD0 #ISPE #ISPETraining #EASE #EASETraining
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Join us for an in-depth discussion on the ISPE Baseline® Guide: Pharma 4.0™. This guide contains tools and advice for companies in achieving their digitization and financial goals while maintaining/improving product quality and meeting regulatory requirements and expectations. In addition, this Guide outlines various starting points, prerequisites, governance structures, and strategies for achieving transformational success tailored to an organization’s size, risk tolerance, flexibility, and maturity level. Speakers include authors Teresa Minero, Michelangelo Canzoneri, Yvonne Duckworth, PE, Paige Kane, PhD, CPIP, Christian Wölbeling, Vinzenz Zauner, and Thomas Zimmer. Register for this complimentary webinar: https://hubs.la/Q02Gm4f30 ISPE webinars can be accessed on-the-go via the free ISPE mobile app, by selecting the "Menu" option: https://hubs.la/Q02Gm60n0 #ISPE #pharma #pharmawebinar #baselineguide #pharma40 #digitalization
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Explore groundbreaking pharmaceutical advancements at the 2024 ISPE Annual Meeting & Expo. Join us in Orlando, Florida, or virtually from 13-16 October for unparalleled networking and learning opportunities among top industry professionals. Take advantage of this offer for the 2024 ISPE Annual Meeting & Expo. This immersive conference will provide attendees with the opportunity to attend workshops, case study presentations, keynote sessions from industry leaders and subject matter experts, as well as post-conference training events, and more. Register now: https://hubs.la/Q02GlVLl0 #ISPE #ISPEAM24 #AM24 #annualmeeting #pharma #pharmaconference
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The unique identification of single glass containers described in this Guide represents a technological advancement that can support the robustness of pharmaceutical manufacturing processes. It encompasses all types of glass primary containers made from tubular glass or molded glass for the containment of pharmaceutical liquids or lyophilized products. Covered topics include: • UID methods/technologies for the different container types • The UID structure • Performance requirements for glass containers • Barcode readability and verification • Radio-Frequency Identification (RFID) technologies • Reading different formats • Automated inspection processes • Traceability in processes Get the guide: https://hubs.la/Q02Gh6TV0 #ISPE #ispeguides #pharmaguides
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Join ISPE Engage Forums and start communicating with industry peers from all levels on the technical topics you face challenges with, or have found solutions for. Start exploring conversations: https://hubs.la/Q02GdXtx0 ISPE Engage can be accessed on-the-go via the free ISPE mobile app, by selecting the "Engage" option: https://hubs.la/Q02GdQT50 #ISPE #ISPEEngage #pharma
Home - International Society for Pharmaceutical Engineering
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Although traditional tank farm systems have long been the cornerstone of buffer preparation, they face challenges that have grown with the expansion of processing scale in the industry. This article explores the concept of the continuous buffer management system (CBMS) as an alternative to traditional buffer tank farm methods. We analyze the historical progression of buffer preparation, highlight the advantages and challenges of the CBMS, and present an overview of its hardware components, system design, and process control strategies to demonstrate the viability of the CBMS as a robust and cost-effective solution for biopharmaceutical buffer management at production scale. Read more in this sponsored article, Continuous Buffer Management System: Large-Scale Buffer Preparation, from Lisure: https://hubs.la/Q02G1Fd_0 #ISPE #Lisure #pharma #cbms
Continuous Buffer Management System: Large-Scale Buffer Preparation
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ISPE has announced the launch of the ISPE Community of Practice (CoP) on Sustainability. The Sustainability CoP joins ISPE’s 20 Global Technical CoPs and supports industry-wide efforts to reliably deliver quality medicines to people. Members of the Sustainability CoP will aim to bring forward solutions for the industry’s unique challenges related to sustainability, gathering insights and engaging in data as well as knowledge-sharing with the pharmaceutical community. The new CoP offers members the opportunity to collaborate on the topic of sustainability, leveraging existing resources such as the ISPE Baseline Guide Volume 6: Biomanufacturing Facilities (Third Edition) and exploring pertinent topics like the influence on reduction of energy consumption in facility design. Learn more: https://hubs.la/Q02G1CcD0 #ISPE #pharma #sustainability #pharmaceuticalengineering #pharmaceuticalmanufacturing #baselineguide #biomanufacturing #pharmafacilities
ISPE Announces a Sustainability Community of Practice
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Having a universal and uniform Common Technical Document (CTD) for all markets, major and emerging, is an aspiration of all pharmaceutical companies. As markets become more familiar with the CTD, especially the quality portion, some drug regulatory agencies are requesting more regional/local documents and customization to CTD documents in accordance with their local interpretation and understanding of the ICH M4Q(R1) guideline, “The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality.” It may be that the agency wants to find specific information quickly and easily, such as the manufacturer of the master and/or working cell bank. Learn more: https://hubs.la/Q02DrkGR0 #ISPE #CTD #pharma #pharmaceuticalengineering #pharmaceuticalmanufacturing
Common Technical Document (CTD) Challenges in Emerging Markets
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Join us in Orlando for the 2024 ISPE International Emerging Leader Hackathon sponsored by Genentech. This immersive event is taking place before the 2024 ISPE Annual Meeting & Expo. We encourage students and recent graduate members to participate in this event, where participants will break out into smaller teams and work strategically to create a solution for the provided problem statement. Register now: https://hubs.la/Q02FWw4t0 #ISPE #ISPEAM24 #hackathon #ISPEhackathon #pharma
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