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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, Paige Kane, Christain Wolbeling, Vinzenz Zauner, and Thomas Zimmer. Register for this complimentary webinar: https://hubs.la/Q02Fr4gh0 ISPE webinars can be accessed on-the-go via the free ISPE mobile app, by selecting the "Menu" option: https://hubs.la/Q02Fr2Sp0 #ISPE #pharma #pharmawebinar

Work with us to build a customized training program to meet your teams' specific needs. We leverage our global membership to find topic experts to create, and instruct, world-class training courses. We offer courses on topics like, Biotechnology, Commissioning and Qualification, GAMP, GMPs, Validation, and more. Keep up with industry innovations and regulations with ISPE Training. Build a custom training program for your team today: https://hubs.la/Q02Fr3XJ0 #ISPE #ISPETraining #PharmaTraining #BiotechTraining

Join speakers Timothy Hajj, Martina Marauli, and Kristel Rens as they discuss the content of the article of the same topic featured in ISPE PE magazine in the March / April 2024 edition. The speakers will cover the high-level content of the article, discussing some of the areas in more detail and will then give the opportunity for questions relating to the article to be addressed and discussed. Register now for this complimentary webinar: https://hubs.la/Q02Ff_h-0 Read more about the topic: https://hubs.la/Q02FfWYr0 #ISPE #ISPEWebinar #PharmaWebinar

Sterile drug production has always been a challenging task to perform in the pharmaceutical industry. There are many requirements to fulfill: to assure product quality, to protect the operator when potent compounds are present, to achieve high levels of efficiency,.…. And all of them must comply with the existing pharmaceutical regulations. In Europe, the main directives to follow are 2001/83/EC and 2017/1572. Annex I of these guidelines for CGMPs was modified in 2022 and it has agitated the sector as human intervention is explicitly not accepted at all under class A conditions. This article will analyse how to address these challenges in different scenarios. Read more in this sponsored article from Azbil Telstar: https://hubs.la/Q02Fh41g0 #ISPE #Telstar #pharma

Meet the 2024 FOYA Category Winner for Operations - Facility Fit - Takeda Austria GmbH. Takeda’s beePFS project is a testament to the company’s commitment to innovation, adaptability, and excellence in project execution. By achieving remarkable success within an accelerated timeline, Takeda has demonstrated its capacity to overcome challenges and deliver outstanding results. The beePFS project enhances supply chain resilience and showcases Takeda’s dedication to pushing boundaries and achieving excellence. The team at the Takeda site in Linz embarked on an exceptional venture, the beePFS project, a pioneering project in Takeda's Super-Fast Track WARP Speed program. This project aimed to revolutionize the process performance qualification (PPQ) timeline and enhance supply chain resilience through a strategic dual-source approach. Despite the challenges posed by the global COVID-19 pandemic and supply chain disruptions, Takeda's beePFS project achieved a remarkable success by making the project 50 percent faster than standard projects previously performed at Takeda and within the industry for similar scope. This has led Takeda Austria GmbH to be recognized as the 2024 ISPE Facility of the Year Award (FOYA) Category Winner for Operations, Facility Fit. Learn more: https://hubs.la/Q02FfXfJ0 #ISPE #FOYA #Takeda

The ISPE Career Center is open to professionals of all levels in the pharmaceutical industry. This valuable resource is a great place to post about new and available roles on your team. Start posting open positions: https://hubs.ly/Q02FfF8l0 #ISPE #pharmajobs #pharma #jobboard #careercenter

Green chemistry is a field of chemistry that focuses on developing and utilizing more sustainable and environmentally friendly chemical processes and products. Green chemistry is a growing field in pharmaceutical laboratories that aims to reduce the environmental impact of drug discovery, development, and manufacturing processes. It involves the application of sustainable and innovative principles to design and optimize chemical processes in a way that minimizes waste, reduces energy consumption, and eliminates the use of hazardous substances. Pharmaceutical labs are increasingly adopting green chemistry practices due to a combination of environmental concerns, regulatory pressure, and economic considerations. Read more: https://hubs.la/Q02Drlh20 #ISPE #pharma #greenchemistry

The ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction materials and updates on current good practices. This edition is aligned with the latest regulatory guidance, including EU Annex 1 (revised 2022), EU Annex 15, the FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, and the FDA draft Guidance for Industry: Current Good Manufacturing Practice for Medical Gases. Get the Guide: https://bit.ly/4buSDZl #ISPE #ProcessGases #GPG #Annex1

Get on demand pharmaceutical training from ISPE. Browse courses from topics covering Biotechnology, GAMP®, Validation, Facilities, HVAC and more. Save on travel expenses and learn on your own schedule. Browse Courses Now: https://bit.ly/4eNUHy9 #ISPE #ISPEtraining #pharmaceuticalengineering #pharmatraining

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