Laetitia Tardif’s Post

✨ #GAMP5 Second Edition will not have any secrets for you anymore ✨   The upcoming ICSVC - International Computerized System Validation Congress, will address your quotidien challenges. These workshops will cover crucial topics ensuring that you are well-equipped to navigate the complexities of today's tech-driven world.🧬   What is on offer?    🎯 Computer Software Assurance (#CSA) and #CriticalThinking during Verification & Validation - Learn how to apply critical thinking and discover how CSA can enhance #DecisionMaking and #RiskManagement during the software lifecycle.   By Sjaak Jacobs, Associate Director QE&A CSV program at Cognizant   🎯 #AgileMethodology for Commissioning, Qualification, Validation and Verification & Validation - Explore how agile principles can transform traditional methods. This session will provide actionable strategies to improve flexibility, reduce timelines, and increase efficiency across your CQV projects.   By Philippe LENGLET, Senior Director for Global R&D Compliance at Dassault Systèmes; and Christophe Girardey, Head of CSV & QA at wega   🎯 #Agile #DataGovernance - In today's fast-paced digital world, traditional data governance struggles to keep up with the speed and complexity of data-driven decision-making. This workshop will introduce participants to an iterative approach that balances the need for control with the demand for rapid innovation. Attendees will learn how to implement agile principles to data governance, data quality, and compliance, while empowering teams to act on insights swiftly.   By Sophie Angenot, Managing Partner at QuaData 🎯 Enabling more efficient and effective C&Q through #GoodEngineeringPractices (GEP) - how GEP can drive efficiency, ensuring that your C&Q processes are both cost-effective and aligned with regulatory expectations. This workshop is essential for those looking to enhance operational performance through structured engineering approaches.   By Simon Thiry, Head of Technoly at Endexia   🔥 And so more - (re)discover the program of two amazing days   Spoiler alert - New technologies are covered as well during the event like #DigitalTwins and #ArtificialIntelligence lead by our partner RealDev - Engineering Group   📅 Join us at ICSVC in Bruxelles, next week - October, 17 & 18   These workshops offer a unique opportunity to learn from leading professionals and elevate your skills in critical areas of software validation in Life Science Industries.   Don’t miss out on these valuable sessions designed to make your work more efficient, compliant, and future-proof!    👉 Register now and stay ahead of the curve!: https://lnkd.in/ekiAKsdD 🌟

🎯 ICSVC - International Computerized System Validation Congress #Day2: Don't Miss These Key Sessions! 🕘 9:30 - 10:30 am | #PlenarySession1 📜 #DataIntegrity & #DigitalTransformation 🎙 David Iroaganachi, Digital Transformation Lead at Merck Life Science 🎙️ Ludivine .Richard, IT Compliance & CSV Expert at IPARDIS CONSULTING 🎙️ Nadia El Mahrad - Williams, Head of IT Solutions at UCB 🎙️ Mathieu Materne, IT Compliance Lead at UCB Description: Through Use cases discover how Digital Transformation enhances your Data Integrity. 🕚 11:30 am - 12:30 pm | #PlenarySession2 📜 #AI as a #MedicalDevice and its use for #Qualification 🎙 Olivier Roecker, CTO at Smart DPS 🎙️ Audrey Gilbert, Medical Devices Expert at Smart DPS Description: Artificial Intelligence for Medical Devices. How to implement it as a medical device and the impact on your validation, and how to use it as a tool for your qualification. 🕑 1:30 - 2:30 pm | #SimultaneousWorkshops 📜 #CSA and #CriticalThinking during #Verification and #Validation 🎙 Sjaak Jacobs, Associate Director QE&A CSV at Cognizant Description: What is CSA and critical thinking ? How is it important and how to use it as an ally during your validation? 📜 #Agile #DataGovernance 🎙 Sophie Angenot, Managing Partner at QuaData nv Description: In Pharma 5.0 data leads the way. How to handle this high volume of data efficiently? 📜 #RiskBased Approach for #AuditTrailReview 🎙 Houssame Nejjari, Senior CSV & Data Integrity Expert at Ellion Belgium 🎙️ Magali DOUILLARD, CSV & Data Integrity Expert at Ellion Belgium 🎙️ Xavier Carey, CSV & Data Integrity Expert at Ellion Belgium Description: Through pragmatic and practical approach the Audit Trail Review will not have secret anymore! 🕓 3:30 - 4:30 pm | Simultaneous Workshops 📜 #AgileMethodology for #CQV and #Verification & #Validation 🎙 Philippe LENGLET, Director for Global R&D Compliance at Dassault Systèmes 🎙️ Christophe Girardey, Head of CSV at wega Description: A unique opportunity to discover the white paper written by ISPE France 📜Efficient and effective #CQV through #GEP 🎙 Simon Thiry, head of Technology at Endexia, LifeCycle hub Description: "I had a dream, a dream of a world in which devices are fit and designed to match perfectly to regulation and user requirements. A world in which we can respect design and build sequences to avoid patch through build and design reality. I would like to share how can we achieve this dream together through Good Engineering Practice from early phasis to the end. " 📜 #Analytics Equipment - #Qualification and #Validation 🎙 Tanja Vietinghoff, Senior CSV Manager at TMV Consulting Description: (Re)Discover the critical path to implement and maintain your Analytics Equipment. Prepare yourself for a day filled with #insightful discussions, hands-on #learning, and innovative technologies! 🚀 👉 Don't have your spot secured yet? Register Now https://lnkd.in/ekiAKsdD

✨ Discover how to tackle the talent shortage in #LifeSciences with the #MetaVerse ! ✨   Are you working in the life sciences sector and struggling with the growing shortage of #QualifiedResources in Computerized System Validation (#CSV)? You’re not alone! At the upcoming ICSVC - International Computerized System Validation Congress, taking place in beautiful Bruxelles, we're thrilled to present a new workshop:   "The #PharmaVerse - How Your Employees Can Become the #Talents Needed?" This innovative workshop will show you how to transform your current workforce into the key talents you need to meet the growing demands of the industry. With cutting-edge training methods, you can #upskill your teams, a rapidly growing and vital area for regulatory compliance in Life Sciences 🧬.   Why attend?   🎯 #Access real #solutions to bridge the gap in qualified talent.   🚀 Upskill your current employees with the #expertise your company needs, rather than seeking external hires.   🥇 Learn how to stay #competitive in a fast-evolving sector where new technologies are reshaping practices.   📅 Join us at ICSVC - International Computerized System Validation Congress in #Bruxelles next October, 17 & 18!   Don’t miss this chance to transform your teams and discover the future of talent development in the Life Sciences Industry.   👉 #Register now to secure your spot: https://lnkd.in/ekiAKsdD 🌟 #pharma #biotech #medtech #csv #automation #newtechnology #IT #Quality

🎯 ICSVC - International Computerized System Validation Congress - #Day1: Don't Miss These Key Sessions! 🕘 9:30 - 10:30 am | #PlenarySession1 📜 #QualityManagementSystems 2.0: Embracing #Digitalization and #Automation in Pharma 5.0 🎙 Sachin Bhandari, Head of CSV and Qualification Standards at Boehringer Ingelheim. This session will explore how the next generation of Quality Management Systems (QMS) can integrate automation and digital tools to improve efficiency, compliance, and innovation within the pharmaceutical industry. Gain insights into Pharma 5.0 and how technology is reshaping quality standards. 🕚 11:30 am - 12:30 pm | #PlenarySession2 📜 #DigitalTwins 🎙 Younes Boukamher, COO at RealDev - Engineering Group. Learn how the Digital Twins is revolutionizing computerized system validation and product lifecycle management in pharma. Use it as validation tool, or how to validate a Digital Twins ? 🤷♂️ 🕑 2:00 - 3:00 pm | #SimultaneousWorkshops 📜 #CSV for #AIbased Systems 🎙 Christophe Girardey Head of CSV & QA at wega Description: As AI systems gain prominence, validating these advanced technologies becomes more complex. This workshop will cover practical strategies (Use Cases) for ensuring compliance (overview of the AI Ragulations) and integrity in AI-driven computerized systems. 📜 #SaMD and Application of #AI in Validation 🎙 Bob Verhoeff MSc & Jan-Bart Hak, from ProPharma. Description: This workshop will focus on the validation of Software as a Medical Device (SaMD) and the application of AI in this context. Learn how to approach the unique challenges and regulatory requirements. 🕓 4:00 - 5:00 pm | Simultaneous Workshops 📜 #Pharmaverse: The VR Training for the Pharma Ecosystem 🎙 Camille Lojou, Co-Founder of Ellion Belgium. Description: Explore how virtual reality (VR) is transforming training within the pharmaceutical ecosystem. This session will showcase Pharmaverse, an immersive training platform designed to enhance learning and retention for pharma professionals. 📜 #DataIntegrity - Gap Assessment and Remediation Plan 🎙 Jordan MARIE-CATHERINE, Head of R&D RealDev - Engineering Group. Description: Data integrity remains a crucial concern in computerized systems. This workshop will cover gap assessments, and how to develop effective remediation plans to ensure compliance with industry standards and regulations. 📜 Topic: #CyberSecurity Using #AI in #MedicalDevices Industries 🎙 Inssata RICOURT & Meshia Cédric Oveneke, PhD Description: With the rise of connected medical devices, cyber security is more important than ever. This session will focus on how AI can enhance security protocols and protect sensitive medical data from cyber threats. Prepare yourself for a day filled with #insightful discussions, hands-on #learning, and innovative technologies! 🚀 👉 Don't have your spot secured yet? Register Now https://lnkd.in/ekiAKsdD

💢 Looking for information and feedback on #AI & #DigitalTwins, and their use in Life Sciences: Join Us at ICSVC - International Computerized System Validation Congress ! These two hot topics are major for this first edition: 🔥 AI-Powered Validation: A Game Changer for Efficiency 🔥 Digital Twins: The Next Frontier in Validation and Compliance Let's go deeper with our Plenary Sessions and Workshops: 🧭Plenary Session - #DigitalTwins: Enhancing Validation and Real-Time Monitoring Discover the power of Digital Twin technology and its application in real-time monitoring and validation. Learn how creating digital replicas of systems can optimize validation workflows, streamline processes, and improve regulatory compliance. 🤩 With a demo from our partner RealDev - International Engineering Group Younes Boukamher 🔍Plenary Session - #AI as #MedicalDevices and its use for #Qualification AI itself is increasingly recognized as a medical device. In this session, discover how to navigate the complex regulatory landscape for validating AI-based medical devices. From design and testing to implementation and validation, you’ll gain practical knowledge to ensure compliance with the latest standards. Audrey Gilbert and Olivier Roecker 🎰Workshop - #CSV for #AIBased Systems In this session, we’ll explore how to tackle computerized system validation for AI-based solutions. Discover best practices for ensuring that AI systems meet validation and regulatory requirements, ensuring compliance and safety through concrete Use Cases. Christophe Girardey 💻Workshop - Software as Medical Devices (#SaMD) and the Impact of AI on Validation As AI becomes a core element of SaMD, the challenge of validating these technologies while adhering to stringent healthcare regulations becomes paramount. This workshop will address the specific impact of AI on SaMD validation processes, with expert insights on balancing innovation and compliance. Bob Verhoeff MSc and Jan-Bart Hak 🔐Workshop - #Cybersecurity Using AI in the Medical Device Industry Cybersecurity is more critical than ever in healthcare, and AI plays a crucial role in safeguarding sensitive data and systems. Learn how AI can enhance cybersecurity measures for medical devices, from threat detection to compliance with regulatory standards, in this essential workshop. Inssata RICOURT and Meshia Cédric Oveneke, PhD 🙌 Secure Your Spot at ICSVC 2024 Today! Register now to ensure you are at the forefront of #innovation in computerized system validation. Come with friends and colleagues – a 20% discount applies for Group Registration, from the same company or not! https://lnkd.in/ekiAKsdD #lifesciences #pharma #medtech #biotech

A few days until the First Edition of ICSVC - International Computerized System Validation Congress 😍 Are you ready? 👇  💎 Proceed to your #registration To register as attendee, fill the form https://lnkd.in/ekiAKsdD The Group promo code is available until the D-Day. All information on the website. You would like to attend only one day? Please contact us at info@icsvc.com   💎 Ensure your #spot – make sure you have paid the fees Once registered, you may receive a Welcome email with your badge and the invoice. ⛔ Sometimes, the security of your company blocks this email. If you have not received anything, please contact us at info@icsvc.com ⚠ As the workshops are under registration, your spot is confirmed only once the payment of the fees is done.   💎 Book your #journey 🌏 You will find all the information regarding how to come in Brussels at the Radisson Collection Hotel on the website, page “All Congress Info” - https://lnkd.in/ecYx_8cS 🗝 A preferred rate to book a room at the Radisson Collection Hotel is available until the 16th of September 2024 💥 . Once registered you will receive all the information on ho to book a room with this preferred rate by email.   💎 Prepare the topics you would like to #share with your #peers during the event In line with the vision of the congress, the slogan is "sharing". This means that speakers will put forward times of sharing with their audience. You will leave with more answers than questions. 🔥 So be prepared and ready to #interact. 🔥 🐯 Discover the speakers of the #plenarysession on the website, page “Plenary Session” – https://lnkd.in/eBntbmKX 🐯 Discover the speakers of the #workshops on the website, page “Speakers” - https://lnkd.in/euRJ8tNy So excited to welcome you in October for this amazing event #lifesciences #CSV #Automation #IT #Quality #Pharma #Biotech #Medtech

Don't miss the opportunity at ICSVC - International Computerized System Validation Congress, next October, to discuss with the experts about the hot topics of the moment 🤓 As a privileged collaboration, ISPE France will be present 😇👌 Take the time to (re)discover the hot topics developed by ISPE, it's an occasion to have a look on the different topics that will be developed during these two-days conferences #lifesciences #AI #Data #plugandproduce #computerizedsystems

When you are told that #MedTech are not without leftovers at ICSVC - International Computerized System Validation Congress 🙌 Welcome our #AI for #MedicalDevices expert duo: Audrey Gilbert and Olivier Roecker 🤩 They will share with you, during the Plenary Session "Artificial Intelligence & Digital Twins", the AI MedTech Opportunities. That's include: 👉 What's an AI?: symbolic and non-symbolic AI, inference engine, decision trees. The break point of AI development. 👉 AI as a MD: What are the alternatives to the #CSV, to be compliant - #AIAct vs #ISO42001. 👉 AI as a tool in MD’s #design: Unit test, license discovery, source code, cyber threat modelling and IP considerations. 👉 AI as a tool for a Regulatory Affairs & Quality Assurance (#RAQA) extended: Highlights AI's use in creating attractive training materials, summarising documents etc. what's forbidden? Discover our duo: 💎 Audrey Gilbert, an expert in #quality and #regulatory affairs for medical devices, has over twenty years of experience in the industry, spanning Class I to III devices. With a Doctorate in Pharmacy, she consults on quality and regulatory affairs, helping startups like Doc2U and Medical Intelligence Service implement #QualityManagementSystems. Her work ensures compliance with #EuropeanRegulations, including Directive 93/42/EEC, Regulation (EU) 2017/745, MDCGs, EN ISO 14971, EN ISO 13485, and EN IEC 62304. Audrey's pragmatic approach, adaptability, and collaboration with technical teams facilitate effective solutions. 💎 Olivier Roecker, an experienced IT executive, currently serves as the #Quality Method and #Cybersecurity Manager for SEBIA's R&D Software and Firmware Department. Since November 2023, he has designed a validation package for non-symbolic AI and revamped #Agile qualification methods. Previously, as Technical Director at Medical Intelligence Service (2021-2023), he redesigned the AI Medvir database and led the AccelRare® project, achieving #ISO13485 & #IEC62304 certification. Olivier has held numerous roles in innovative startups, driving technological advancement through #IT system transitions, #SaaS offerings, and #DigitalTransformation. His career includes significant project management at Lilly France, with expertise in programming languages, databases, and tech industry standards. Register Now ! https://lnkd.in/ekiAKsdD 🤫 Don't forget the current promo - info on the ICSVC - International Computerized System Validation Congress LinkedIn Page