🌟 On November 20th we had the pleasure of joining the workshop "Development, Qualification, and Maintenance of Filtration System Validation" in Casablanca. We would like to thank the AMIP for their warm hospitality and the opportunity to share our expertise with its members. Our gratitude also extends to Pemflow for their valued collaboration and expertise. 🙏 A special thanks goes to all participants: your enthusiasm, insightful questions, and practical contributions enriched the discussions, turning the workshop into a unique moment of exchange and learning. 👉 Stay tuned to discover all the exciting initiatives we have planned for the upcoming year! #commitment2innovation #highqualitycontrols #processvalidation ----------------------------------------------------------------------------- 🌟 Le 20 novembre, nous avons eu le plaisir de participer à l'atelier "Développement, Qualification et Maintien de la Validation d'un Système de Filtration" à Casablanca. Nous tenons à remercier chaleureusement l'Association Marocaine pour l'Industrie Pharmaceutique AMIP pour son accueil convivial et l'opportunité de partager notre expertise avec ses membres. Notre gratitude s'étend également à Pemflow pour leur précieuse collaboration et leur expertise 🙏 Un merci spécial à tous les participants: votre enthousiasme, vos questions pertinentes et vos contributions pratiques ont enrichi les discussions, faisant de cet atelier un moment unique d'échange et d'apprentissage. 👉 Restez connectés pour découvrir toutes les initiatives passionnantes que nous préparons pour la nouvelle année!
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Unlock the Secrets of EMS at ISPE GDP 2025! Join Andre Ng, Technical Director at Cynotex, on 8-9 January 2025 at Bangi Resort Hotel as he presents: “Environmental Monitoring Systems: Key Considerations and Real-World Case Studies.” Gain insights into: ✅ Regulatory requirements for EMS ✅ Key factors for critical environments ✅ Smart questions to select the right EMS ✅ Case studies & lessons learned Don’t miss this chance to elevate your pharma quality assurance game! Ellab - Validation & Monitoring Solutions LWS (Lighthouse Worldwide Solutions) #EnvironmentalMonitoring
Keeping Pharma Quality in Check: EMS Unveiled at ISPE GDP Seminar! On 8-9 January 2025 at Bangi Resort Hotel, Andre Ng, Technical Director at Cynotex, will present “Environmental Monitoring Systems: Key Considerations and Real-World Implementation Case Studies.” In the training session, Andre will provide participants with valuable insights into: - Understanding regulatory requirements and guidelines for environmental monitoring systems. - Key factors to consider when selecting systems for critical environments - Identifying the right questions to ask when selecting an Environmental Monitoring System (EMS) - Real-world case studies highlighting successful deployments and lessons learned Through his engaging and practical approach, Andre aims to equip participants with the knowledge and tools necessary to select and implement effective environmental monitoring systems, ensuring compliance and enhancing system performance in their respective industries. This is an unmissable opportunity to elevate your understanding of EMS and its transformative role in pharmaceutical quality assurance. 📍 Where: Bangi Resort Hotel 📅 When: 8-9 January 2025 🔗 Register now to secure your spot: https://lnkd.in/g-WUyQdH #MYISPE #2025ISPEGDPSeminar #EMS
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💊 Vous êtes acteurs de l'industrie pharmaceutique et des dispositifs médicaux? Vous nécessitez un accompagnement vous garantissant un support en qualité et en affaires réglementaires? 🚀 Contactez moi pour en savoir davantage sur notre centre de Services dédié : QARA
🔍 Dive into the complex world of Medical Devices and Pharma ! Our work enables healthcare professionals to produce with peace of mind, ensuring that vital devices and treatments reach those in need as quickly as possible, while meeting quality and safety standards. In a sector where regulations are constantly evolving, the race for efficiency is more intense than ever. Today's challenges are significant, but we have the solution: QARA, our dedicated service center. At QARA, our expertise meets speed. We understand the unique challenges that Life Science companies face, and we are here to help them navigate this complex landscape with agility. 🚀 Want to learn more about how QARA can turn your challenges into opportunities?
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Last Few Days to Apply for Funding in @Innovate UK Sustainable Medicines Manufacturing Innovation Programme The deadline for applications to two key funding opportunities in the Sustainable Medicines Manufacturing sector is fast approaching. These competitions offer substantial support for pioneering projects aimed at enhancing sustainability, efficiency, and innovation in the pharmaceutical industry. Expression of Interest (EOI) - This is an opportunity to submit a preliminary expression of interest, detailing your proposed solutions and innovations in sustainable medicines manufacturing. 👉 Submit Your EOI Collaborative Research & Development (CR&D) This competition supports collaborative projects that aim to develop innovative solutions for sustainable medicines manufacturing. It is an excellent opportunity for organisations working together across sectors to secure funding for cutting-edge research and development initiatives. 👉 Apply for CR&D 💡Still Seeking Collaboration Partners? If you have not yet secured collaboration partners for your project, we encourage you to review the latest collaboration document, which lists potential partners and collaborative opportunities. This is an invaluable resource for those seeking to form partnerships before submitting their applications. 👉 Access the Collaboration Document We strongly encourage all eligible parties to submit their applications promptly to contribute to the future of sustainable medicines manufacturing. #TMM #Sustainability #FundingOpportunities #EOI #CRD #SMMI
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👁️🗨️L’équipe d’ATESSIA, Life Science Advisors se renforce en CMC pour répondre à vos enjeux de développement et transfert industriel. N’hésitez pas à nous contacter pour vos projets
[ WELCOME ] 🎉We are delighted to welcome Jenny Almendra to the ATESSIA, Life Science Advisors team! She will hold the position of Senior CMC & Regulatory Affairs Advisor. 🖌 You can learn more about her career by reading her presentation on our website (in French and English): https://lnkd.in/epMpPyje ✨ The whole team wishes her a warm welcome! ✨ #Welcome #TeamAtessia
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Navigating a Greener Future: The GDP-UCI “IPEL” Project Debuts at the Pharma Logistics Summit in Barcelona The Good Distribution Practice - Universal Compliance Initiative (GDP-UCI) was thrilled to announce the official launch of the Integrated Pharmaceutical Eco-Lanes (IPEL) project, at the Pharma Logistics Summit in Barcelona on October 11th 2024. Hosted by the Barcelona Port Authority, this event gathered pharmaceutical leaders to discuss how IPEL is set to revolutionise pharmaceutical logistics through sustainable, GDP-compliant, intermodal freight lanes. The first phase of the project involves proof-of-concept pilot exercises linking Spain to Poland and Hungary to Benelux. These will demonstrate how intermodal solutions can drastically cut carbon emissions while ensuring product safety, security and integrity. Alan Kennedy, Executive Director of GDP-UCI, emphasized: “The IPEL project marks a pivotal moment for pharmaceutical logistics. Collaboration is essential to create eco-friendly transportation solutions that meet strict GDP standards.” Key Benefits of IPEL include: SUSTAINABLE LOGISTICS: Prioritizing rail, sea, and waterways to reduce carbon emissions. GDP COMPLIANCE: Ensuring the highest standards of product safety and integrity. COST EFFICIENCY: Leveraging economies of scale for economic and environmental advantages. Interested parties can learn more about participating in upcoming pilots and commercial services by contacting IPEL@GDP-UCI.org. Let’s collaborate for a sustainable future! #PharmaLogistics #Sustainability #GDPUCI #IPEL #PharmaInnovation #BarcelonaSummit
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SIPOC : Un Outil Essentiel pour l'Industrie Pharmaceutique L'optimisation des processus dans l'industrie pharmaceutique est essentielle pour garantir la qualité, la conformité et l'efficacité. Parmi les outils Lean Six Sigma, le SIPOC (Suppliers, Inputs, Process, Outputs, Customers) se distingue par sa simplicité et son efficacité à clarifier les processus. --- Qu'est-ce que le SIPOC ? Le SIPOC est une représentation visuelle permettant de cartographier un processus en cinq éléments clés : 1. Fournisseurs (Suppliers) : Les entités ou départements qui fournissent les intrants. 2. Intrants (Inputs) : Les ressources nécessaires pour exécuter le processus (matériaux, données, etc.). 3. Processus (Process) : Les étapes principales du processus. 4. Sorties (Outputs) : Les résultats générés par le processus. 5. Clients (Customers) : Les destinataires finaux des sorties. Cet outil est souvent utilisé au début d'un projet d'amélioration pour clarifier la portée et établir une compréhension commune. --- Exemple d'utilisation en industrie pharmaceutique Étude de cas : Fabrication d'un lot de comprimés Fournisseurs : Fournisseurs de matières premières (API, excipients). Intrants : API, excipients, fiches techniques, équipements de production. Processus : Pesée → Mélange → Compression → Enrobage → Contrôle qualité. Sorties : Comprimés finis conformes. Clients : Laboratoires internes, distributeurs, hôpitaux. L'utilisation du SIPOC permet ici de : Clarifier les relations entre chaque étape du processus. Identifier les points critiques à optimiser (ex. délais d'approvisionnement). Mettre en lumière les attentes des clients finaux pour ajuster les spécifications. --- Avantages du SIPOC dans l'industrie pharmaceutique 1. Conformité réglementaire : En s'assurant que chaque intrant et chaque sortie répondent aux normes (ex. GMP). 2. Communication efficace : Une vision claire pour toutes les parties prenantes. 3. Réduction des erreurs : En identifiant les points faibles du processus. 4. Support à l’amélioration continue : Base pour des analyses plus approfondies (FMEA, SPC). --- En conclusion, le SIPOC est bien plus qu’un simple outil de cartographie : c’est une première étape stratégique pour maîtriser la complexité des processus pharmaceutiques. Qu’en pensez-vous ? Avez-vous déjà utilisé le SIPOC dans vos projets ? Partagez vos retours d’expérience en commentaire ! #SixSigma #Lean #IndustriePharmaceutique #SIPOC #AméliorationContinue
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Formation : Fondamentaux du Quality by Design (QbD) pour renforcer la R&D de votre entreprise avec Christian Valentin 💡 Optimisez vos processus de développement grâce à une approche méthodologique innovante ! Le Quality by Design (QbD) révolutionne l’industrie pharmaceutique en intégrant la qualité dès la conception du produit. Cette approche, soutenue par les agences réglementaires, permet de réduire les coûts, optimiser les délais et renforcer la conformité en identifiant et contrôlant les sources de variation. Grâce à des outils analytiques avancés, le QbD favorise l’innovation et la flexibilité dans les processus de développement. ✅ Ce que vous allez apprendre : - Comprendre l’approche QbD en lien avec les cGMP. - Découvrir les fondamentaux et les principaux outils QbD : QTPP, analyse de risque, DoE et design space. - Appréhender les liens entre CQA produit et CPP procédé. - Explorer l’importance d’une approche multidisciplinaire intégrant le développement des procédés, l’analytique, l’assurance qualité et les affaires réglementaires. 👉 Pour qui ? Professionnels de la R&D, de la qualité et des affaires réglementaires souhaitant intégrer une approche performante pour améliorer la robustesse et l'efficacité des processus de développement. 📅 Retrouvez toutes les informations et inscrivez-vous pour 2025 : https://lnkd.in/gm_29kEg #Formation #QualityByDesign #Pharma #Biotech #Innovation #DéveloppementPharmaceutique #Qualité #Réglementaire
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🚀 I invite you to join the webinar "From Theory to Practice: Real-World RBQM" on July 30-31! 🌐 I am excited to announce that I will be one of the speakers at this important event organized by Cyntegrity Germany GmbH. We will dive into real-world examples and best practices for implementing Risk-Based Quality Management (RBQM) in clinical trials. 🔍 Topics covered in the webinar include: Overcoming RBQM challenges in real-world settings Effective strategies for enhancing quality and reducing risks Practical tips and tools for successful RBQM implementation Don't miss this opportunity to learn about the latest trends and cutting-edge approaches from industry-leading experts! 📅 Dates: July 30-31 📍 Register and find more details here: Day 1 https://lnkd.in/dq__ATRd Day 2 https://lnkd.in/dFCmfQyh I look forward to seeing you at the webinar and discussing all the relevant topics in this field. See you there! #RBQM #Webinar #ClinicalResearch #QualityManagement #RiskManagement #Cyntegrity
Special Offer for Workshop Participants: We offer all participants a 30% discount voucher for the RBQM Essentials—Green Belt e-Training course. This is an excellent opportunity to support the practical hands-on session with the theory behind it. Read more about the Green Belt course here: https://lnkd.in/d7GcsaMY 📅 Workshop Details: Dates: July 30 and 31 Duration: 1.5 hours per session Appointments: Part 1: July 30, 2024, start 17:00 CEST, 5 PM EDT Part 2: July 31, 2024, start 17:00 CEST, 5 PM EDT Workshop Highlights: >> Real-World RBQM Stakeholder Meeting Simulation >> Interactive Sessions with Whiteboard Brainstorms and Polls >> Demonstration of how the theory is applied in a real RBQM system For a detailed workshop program and registration, please visit our Upcoming Events page: https://lnkd.in/e35wZ7d3 See you at MyRBQM Academy! Best regards, Anastasia Shapovalova Dr. Ritwika Kar Kateryna Koliadiuk Johann Proeve #ClinicalTrials #ClinicalResearch #Pharma #BioTech #RBQM #ICH #GCP
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La démarche Qualité indispensable pour augmenter l’efficience de nos tâches au quotidien
𝘾𝙤𝙣𝙣𝙖𝙞𝙨𝙨𝙚𝙯-𝙫𝙤𝙪𝙨 𝙫𝙧𝙖𝙞𝙢𝙚𝙣𝙩 𝙋𝙃𝙎𝙌 ? ⚙️Démarche de certification Qualité ISO 9001-QMS Pharma®️ 🧑🏼⚕️Expérimentation article 51 OSyS®️ 🍀Label ECOR 👩💻Logiciel Qualité Officinal LQO 🎓Organisme de formation certifié Qualiopi 💊Référentiel et outils PDA 🤝Dossier management RH L'association Pharma Système Qualité, c'est tous ces projets d'innovation et tant d'autres… Merci aux groupements partenaires ! #ISO9001 #santé #pharmacie #ecor #PDA #RH
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🎉 Exciting Announcement! 🎉 We are thrilled to share that our principal, Haşim Solmaz from LWS (Lighthouse Worldwide Solutions), will be presenting at the 2024 ISPE Malaysia Affiliate Conference & Exhibition on June 26-27, 2024, at Pullman Kuala Lumpur. 🌟 Join us for his insightful presentation, "Decoding Industry 4.0 and the Transforming Impact on Cleanroom Monitoring," where he will delve into the profound effects of Industry 4.0 on cleanroom manufacturing and monitoring. Topics Covered: 🔹 What is Industry 4.0? 🔹 Key components of Industry 4.0 🔹 What is Pharma 4.0? 🔹 Key components of Pharma 4.0 🔹 ISPE & Pharma 4.0 🔹 What is Industry 5.0? 🔹 Aseptic manufacturing in Pharma 4.0/5.0 🔹 Digital Environmental Monitoring data 🔹 Data Integrity and Governance in Pharma 4.0 🔹 What is a Smart Particle Counter? 🔹 Digital EM Program 🔹 Digital enhancements in today's smart particle counters 🎤 About the Speaker: Haşim Solmaz is the General Manager of Lighthouse Worldwide Solutions EMEA Operations, with extensive expertise in cleanroom design, environmental monitoring systems, pharmaceutical manufacturing, and regulatory concerns. He is a founding chair of the Cleanroom Technologies Society of Turkey (CTS) and holds prominent roles in ISO TC209, TSE, ICCCS, and IEST. 🌐 Don’t miss this opportunity to gain valuable insights from a leading expert in the field! See you there! 👋 #GoingBeyondBoundaries #MYISPE #CleanroomMonitoring #Pharma40 #ConferenceAndExhibition
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