Julia Deny

🌐 Biosimilars Quiz ! 💊 👩‍⚕️ Test your knowledge on biosimilar drugs with this mini-quiz ! Which statements about biosimilar drugs are correct ? a) A biosimilar is a biologic drug authorized based on demonstrated similarity to an already authorized biologic drug. b) A biosimilar is comparable to the original active compound in terms of application, dosage, and efficacy. c) A phase III clinical trial is not necessary to confirm the efficacy and safety of the drugs. d) An authorized biosimilar is just as effective and safe as the reference drug. => Find the correct answers in the comments. #Healthcare #Biosimilars #MedicalQuiz

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This is part 1 of our series ‘Fundamental risk concepts’. In this first part we will cover : → The first definitions → Hazard & sequence of events → Hazardous situation  → Risk → Detectability → Risk estimation 🔜 Next week we'll continue this series, looking at risk control, risk acceptance & more... ✅ To go further, implement our medical device risk management methodologies and templates: https://lnkd.in/eTw2VVXp ❗ PS: No bob was injured writing this series of ‘Fundamental risk concepts’.

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💊 Pharma GDP-RP Training One week to go => last chance to subscribe 📅 5 - 6 June 2024 - What do you need to know as a GDP RP person. - How to deal with deviations in the cold chain. Don' miss this interactive training. Only 3 seats left To secure your place visit our website: https://lnkd.in/e2hVHRJ7 #GDP #Training #Pharma #SupplyChain

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Find the answers to these questions and more as Nessiem Samuel discusses Lifecycle Management on Commissioning: https://lnkd.in/ejb2G_CV #Commissioning #Qualification #Validation #CSV #CSA #Quality #GxPImpactConsulting #LifeSciences #Pharma #Biotech #Engineering

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Are you confident in your quality management system (QMS)? Understanding how to identify potential pitfalls is crucial. In this free whitepaper, we break down the core building blocks of a solid QMS so you can be confident in your system. Download here: https://azzur.co/43ZYMum #CAPA #QualityManagementSystem #LifeScience #ISOStandards #GMP

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Large-scale pharma webinars ARE possible without compliance headaches. You just need to know the secrets of how to do them… Lev Cribb (Webinar Experts) will reveal these secrets alongside Pierre Metrailler (SpotMe) at our 30-min webinar on June 11 at 10 am ET | 4 pm CET. Things they will cover: 👉 Insights into real compliance issues plaguing pharma webinars today 👉 How programmatic webinars can remove compliance headaches & improve pharma webinars 👉 Tips to help you scale pharma webinars while remaining compliant Register now. Link in first comment 👇 #LifeSciences #Pharmaceuticals #Pharma #Omnichannel #Events #EventProfs #PharmaIndustry #EventTech #Webinars

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🎙️ Unlock insights into compliance with Annex 1! Dive into an on-demand webinar recording from Cencora PharmaLex, exploring strategies for ensuring compliance with EudraLex Volume 4, Annex 1, "Manufacture of Sterile Medicinal Products." Learn to assess compliance levels, develop remediation plans, and overcome challenges faced by SMEs. Discover the importance of Quality Risk Management (QRM) and Contamination Control Strategy (CCS) for maintaining compliance. Watch now from the convenience of your desk! https://hubs.ly/Q02trvbZ0 #PharmaLex #Annex1 #Webinar #EUPharma24 #GenerisEPOS

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[Pharma - Microbiology] 🦠 Do you have Out-of-Specification (OOS) results? 🌟 When faced with an #OOS, it can be quite stressful. The pressure is on to investigate as quickly as possible, with the Quality Assurance team monitoring us 24/7 for rapid results. However, with growth-based methods, it's simply not feasible... we have to wait several days for the cultures to grow! 🧫⏳ That's why the use of Rapid Microbiological Methods (hashtag #RMM) should be considered. To learn more about it, check out this "super" article by Tony Cundell. 📄🔍 https://lnkd.in/eGZbSUtM ----- Follow SuperMicrobiologists for more info about hashtag #Microbiology🔔 #SuperMicrobiologists the website for #microbiologists who love to... bug into the smallest details 🦠 😁 American Pharmaceutical Review

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Excipient, an inert part of your formulation, right? Then, why there is a lot of buzz around excipients ? Even though excipient is an inert part of it have much more to offer when it comes to patient safety. As per Eu guidelines on excipient risk assessment it's responsibility of MAH to ensure the quality of excipients and GMP components of excipients manufacturers. Here is a deep dive into the Excipients Risk assessment guidelines by the EU.

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🚨 WEBINAR Local Networking Group Virtual Event: A Comprehensive Assessment of smart Medical Devices with Regulatory Affairs Professionals Society (RAPS) feat. Eurofins E&E France 📍 Vendredi 14 juin 2024 (13:30) 💬 Philippe Sissoko ➡ Inscription : https://lnkd.in/e8Pdf2eJ This event will be held in French The integration of #wireless technologies such as #Bluetooth, #WiFi, and #RFID into smart medical has opened new frontiers in #healthcare. These devices, capable of monitoring patient health and delivering therapeutic interventions, are transforming patient care. However, the connectivity of these #medicaldevices introduces unique challenges in terms of cybersecurity and reliable communication. Join us as we navigate the complex regulatory landscape of smart medical wireless, sharing insights and strategies to ensure #cybersecurity and reliable connectivity in these innovative devices. This webinar will provide a platform for industry experts, #regulatory professionals, and healthcare providers to collaborate and advance the safe and effective use of MDs in the era of smart healthcare.

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-Celebrating Continuous Improvement through CAPA: Why It Matters. For full episode check: https://lnkd.in/er-HnvST Monir El Azzouzi Vincent F. Cafiso #easymedicaldevice #medicaldevice #regulatorycompliance

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-Importance of Design and Alert Systems in Risk Management For full episode check: https://lnkd.in/ebtvrARx Monir El Azzouzi Amandine Broussier #easymedicaldevice #medicaldevice #regulatorycompliance

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🗝OUT NOW in the JMDR May 2024 issue: 🗝US FDA finalises rule incorporating ISO 13485 into new Quality Management System Regulation (QMSR) Are you aware of the revisions in the FDA’s Quality System requirements for medical devices? This new article from GlobalRegulatoryPress.com will help you understand: 🗝the content of the QMSR 🗝key differences between the QSR and QMSR 🗝and steps that manufacturers should take to prepare for implementation of the QMSR. by Pamela Forrest and Amy Leiser https://lnkd.in/dKNMZZNy #regulatoryaffairs #medicaldevices #samd #medizinprodukte #dispositivimedici #dispositifsmedicaux #dispositivosmedicos

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The evaluation of two dissolution curves for test and reference is like the cherry on the cake. You should understand API, reference, your test prototype with proper intermediate (e.g. granules) characterization, and overall pharmacokinetics. All these steps significantly minimize your risk of clinical trial failure. Check our new Labka Reel and lab.kapaji.eu

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Part II of the article on design controls that depicts how to integrate design control and risk management process. #Risk Management # Design Controls

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Blitz Quality Function Deployment is one of my favourite quality tools. I recommend the QFD use anytime you are working, for example, on a white labelling project and/or when improving a product or in launching new products in-house. The 7 large phases to the modern QFD: Project Definition - what are the critical goals? What is critical? Semantic Analysis - doing a gemba, listen to costumers. What costumer tell us? Why? What can we offer. (Costumer is also internal departments and processes upstream and downstream) Situation Analysis - what jobs are the costumers doing and what contexts are possible? What other applications are possible? Goal Analysis of what costumers think of their needs? What needs are missing or possible or implied? Goal Analysis of what are the most important needs. What is the performance expectation? How satisfied the costumer is at the moment? Project Strategy - how can we meet costumer top needs? Where should we focus on? Downstream deployments - what further analysis might be necessary and what we must master?

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"Inspection Ready" often sounds like a buzzword. It shouldn't be. True Inspection Readiness may sound like a mirage, a myth, an unachievable goal, but when everyone does as expected, it's not that hard to achieve. In 3 blogposts I'll bring some ideas, suggestions, tips and tricks to support in your preparation toward a good level of Inspection Readiness. Please check out this first post: https://lnkd.in/ei_6sjPE #InspectionReady #CAPA #QbD

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