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Join us at the Cleaning Process & Validation Conference for a deep dive into the most crucial topics in pharmaceutical cleaning processes. 🔥 This impressive lineup of speakers and topics ensures a comprehensive understanding of the latest advancements and strategies in cleaning validation. Don't miss the opportunity to enhance your expertise and network with industry leaders. 📅 November 7-8, 2024 📍 Munich, Germany & Online 📑 Request full agenda: https://lnkd.in/da4z3R6h Day 2 Topics: ✔ASTM E55.11 Clean by Design: Richard Hall Hall from Rattiinox S.r.l. will introduce holistic strategies to enhance cleanability and operational efficiency. ✔Contamination Control Strategy: Dr. David Vincent, from VTI Life Sciences will provide an overview of contamination control plans and hygiene in cleanrooms. ✔Annex 1 and COP Machines: Fabio Buscaglia from IWT Pharma will discuss the latest on regulatory updates and where we are at Clean Out of Place machines. ✔Permitted Daily Exposures (PDEs): Dr. Martin Kohan, from Trinity Consultants - SafeBridge Europe, Limited will delve into calculating PDEs and their role in cleaning validation. ✔Flexible Single-Use Containment Systems: David Val from ILC Dover will explore the benefits of disposable containment solutions in meeting regulatory standards. Speak Pharma #SpeakCleaning #CleaningValidation #PharmaHygiene #IndustrionHygiene #CIPAdvantages #RiskAssessment #ManufacturingQuality #ValidationStrategies #PracticalApplications #CollaborativeLearning #QA #Digitalization #CleanByDesign #CIP #COP #Annex

Coldchain management becomes more and more important in Big Pharma and Biotech. You want a reliable product. A product you can depend on. For patient materials, clinical trials or critical cells. And of course you care about the environment, so you demand low energy consumption. We got it all. Let’s talk. We listen. And we bring you solutions. #LOFM #PHCbi #PHCgroup #coldchain #clinicaltrials #energysaving #reliability #ULTfreezer

📌 Last chance to register... Registrations close tomorrow! 👉 bioMérieux Pharma Quality Control is pleased to partner with PDA Asia Pacific to present Gilberto Dalmaso PhD speaking about 𝙀𝙢𝙗𝙧𝙖𝙘𝙞𝙣𝙜 𝙄𝙣𝙣𝙤𝙫𝙖𝙩𝙞𝙤𝙣: 𝘼𝙣𝙣𝙚𝙭 1 𝙖𝙣𝙙 𝙩𝙝𝙚 𝙎𝙝𝙞𝙛𝙩 𝙩𝙤 𝙍𝙖𝙥𝙞𝙙 𝙈𝙞𝙘𝙧𝙤𝙗𝙞𝙖𝙡 𝘿𝙚𝙩𝙚𝙘𝙩𝙞𝙤𝙣 𝙞𝙣 𝙎𝙩𝙚𝙧𝙞𝙡𝙚 𝘿𝙧𝙪𝙜𝙨. 👉 Register now for this free webinar, sponsored by bioMérieux at 2pm (GMT+8) on 23 November. Click the image below to register today! 👉 Follow bioMérieux Pharma Quality Control on LinkedIn for more information about pharma industry events, news, regulations and technologies. #pharmaceuticalmanufacturing #YourAllyInAdvancingQuality

Hey ISPE San Diego Chapter! We want to know what expertise YOU would like to share with your fellow ISPE members. Looking forward to kicking of 2024 with this event! Please reach out to me if you have any topics in mind, or if you have any questions.

Did you know the biopharma sector loses a staggering USD 35 billion annually due to temperature excursions? 😱💸 That’s a massive sum comprising lost products, replacement costs, wasted logistics resources, and missed opportunities in clinical trials! 📦🔥 An effective temperature mapping protocol can significantly reduce these losses. But it’s not without its challenges. 🌡️⚠️ Common mistakes can lead to inefficiencies and non-compliance. ❌Here are the top four mistakes to avoid when creating a temperature mapping protocol: 📝 𝗡𝗼𝘁 𝗵𝗮𝘃𝗶𝗻𝗴 𝘁𝗵𝗲 𝗻𝗲𝗰𝗲𝘀𝘀𝗮𝗿𝘆 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻: The lack of appropriate information about the equipment and product can lead to an ineffective protocol. 🌡️ 𝗜𝗻𝗮𝗱𝗲𝗾𝘂𝗮𝘁𝗲 𝘁𝗲𝗺𝗽𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗺𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗲𝗾𝘂𝗶𝗽𝗺𝗲𝗻𝘁: Using unqualified equipment or not properly informing the qualification result can result in inaccurate temperature mapping. 📋 𝗣𝗼𝗼𝗿 𝗚𝗼𝗼𝗱 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 (𝗚𝗗𝗣): Insufficient documentation can cause confusion and errors during temperature mapping. 🔍 𝗟𝗮𝗰𝗸 𝗼𝗳 𝘁𝗿𝗮𝗰𝗲𝗮𝗯𝗶𝗹𝗶𝘁𝘆: It's difficult to monitor and address issues effectively without clear traceability between collected temperature data and any deviations. What if you could turn this around? Utilizing your temperature mapping data to improve compliance and efficiency is the key. 🔑🔄 Join us for a groundbreaking webinar where our industry experts, Arsalan Bassir and Chris Maughan, unveil practical strategies inspired by real-world examples that will completely transform how you use your temperature mapping data. 🎥💻 🌍Imagine a world where you can predict and prevent mapping failures, gain actionable insights to proactively resolve issues, and define operating limits with surgical precision. This webinar gives you the knowledge and tools to realize this vision. 🎓🔬 🗓️ Mark your calendars for September 28th, 16:00 CET Berlin and get ready to unlock the hidden potential within your reports. Register now to claim your superhero spot and take the first step toward making compliance as cool as ice! ❄️✨ 👇 𝗙𝗼𝗹𝗹𝗼𝘄 𝘁𝗵𝗲 𝗹𝗶𝗻𝗸 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗺𝗺𝗲𝗻𝘁 𝘀𝗲𝗰𝘁𝗶𝗼𝗻 𝗯𝗲𝗹𝗼𝘄 𝘁𝗼 𝗿𝗲𝗴𝗶𝘀𝘁𝗲𝗿 👇📲 A big thank you to our event partner, Eupry, a provider of state-of-the-art environmental monitoring systems. Their support makes this event possible! 🙌💙🚀 #GMP #Pharma #Pharmaceutical #Quality #PharmaceuticalManufacturing #temperaturemonitoring

Synensys was awarded a research contract by The U.S. Food and Drug Administration (FDA) to conduct the study “Improving the Reliability, Interoperability, Agility, and Quality of Laboratory Data Exchanges using System Safety Engineering Methods” under an FDA Broad Agency Agreement. With over 13 billion laboratory tests performed across the U.S. each year, patients, providers, public health officials, and researchers depend on reliable laboratory data to diagnose, treat, prevent, and manage disease, especially during the COVID-19 pandemic. Synensys and their project team, including experts from the Massachusetts Institute of Technology, the University of Nebraska Medical Center, the College of American Pathologists, Deloitte Consulting, LLP, and JP Systems applied safety engineering methods to assess, measure, document, and analyze the safety and quality of the U.S. laboratory data ecosystem. Our research team used the System Theoretic Process Analysis (STPA) methodology to proactively identify and highlight systemic safety flaws and opportunities for future system redesign. Click the link below to read the Project Overview, Executive Summary and the Full Report: https://lnkd.in/e9Vv6Wsh

❌Here are the top four mistakes to avoid when creating a temperature mapping protocol Join Qualistery webinar and follow Arsalan Bassir from Eupry

Dive into the heart of innovation at #DIAEurope2024! Explore eleven tracks that span the entire drug development lifecycle, including the CMC & Product Quality Track. Led by the experts Sofia Ribeiro (Bayer) and Matthew Popkin (GSK), this track explores the most recent developments in science, technology, and regulations impacting CMC and GMP related activities. Ready to be inspired? Watch the video below as Sofia shares insights into the current CMC landscape and why DIA Europe serves as the ultimate platform for fostering crucial discussions in this field. Hurry, there’s still time to secure your spot! Learn more here: https://bit.ly/3qDyjTV. #Conference #LifeSciences #CMC #RegulatoryAffairs

We're excited to share our latest video on the essentials of Good Manufacturing Practice (GMP) in clinical research! Learn how GMP ensures the safety, quality, and efficacy of medicinal products, safeguarding patient health and maintaining pharmaceutical integrity. Watch the video to gain valuable insights and stay ahead in the industry. 🔗https://zurl.co/o6j6 #GMP #ClinicalResearch #PharmaceuticalIntegrity #PatientSafety #QualityAssurance

Laboratory, Informatics and Patient Safety colleagues, Synensys presents a recent overview of the laboratory ecosystem from a systems safety lens. Various perspectives of stakeholders interviewed (their views of the healthcare system) inform scenarios that show the interactions between laboratories, In Vitro Diagnostics, LISs, EHRs, data standards, regulations, and safety issues that may arise illustrating the complexity of healthcare. Recommendations to try to mitigate these risks across healthcare are presented.