✴️ Last Week, MAIN5’s experts Marko Lubura, Jens Marburg and Managing Partner Alexander T. had the privilege to attend the 17th GAMP D-A-CH Conference. With over 140 participants, the event proved to be an outstanding platform for exchanging ideas, fostering collaboration, and networking within the #Quality and #Compliance community. Held on the 3rd and 4th of December, the conference brought together GxP Quality and CSV Compliance enthusiasts, thought leaders, and industry authority representatives to discuss key topics and share experiences that will influence the future of the life sciences sector. Among the many compelling presentations, we’d like to highlight: 🔶 Yves Samson’s talk on “Von Daten zum Produkt”, which delivered valuable insights into the Pharma Product Lifecycle—from data to the final product. 🔶 Sascha Howey’s presentation on “Cybersicherheitsrisiken und Resilienz: Wie wappne ich mich für den Ernstfall”, which shed light on cybersecurity risks, regulatory expectations, and unique challenges within the Life Sciences industry. These sessions, along with the vibrant discussions they inspired, underscored the importance of ongoing dialogue and innovation in navigating challenges and opportunities in the industry. Looking forward, we’re excited about the future of the GAMP D-A-CH series. #MAIN5 is proud to announce that we’ll be actively participating in the upcoming GAMP D-A-CH Forums in March and September, as well as next year’s GAMP D-A-CH Conference. Our experts are eager to contribute to these discussions, helping shape the future of the Life Sciences industry. 🌟 Let’s continue to drive excellence in #Quality, #Validation, and #Compliance!
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I am really looking forward to the next ISPE Gamp Community of Practice (Cop) UK Forum meeting: 𝐓𝐮𝐞𝐬𝐝𝐚𝐲 19𝐭𝐡 𝐍𝐨𝐯𝐞𝐦𝐛𝐞𝐫 - 𝐆𝐒𝐊 𝐒𝐭𝐞𝐯𝐞𝐧𝐚𝐠𝐞 (08:30 - 16:30 𝑮𝑴𝑻). These educational compliance events are free for industry to attend - because of the generous support from sponsors. In this case GSK and Emmerson (𝐓𝐇𝐀𝐍𝐊 𝐘𝐎𝐔). The agenda for these events are based, in part, on valuable feedback from attendees at the previous meeting - click on the link below to register - places will go quickly.......... The full agenda is listed in the registration page, but includes mouth watering topics such as: - Interactive Session – How do defects escape into the wild? - Data Lakes & Analytics (𝘗𝘪𝘤𝘬 𝘰𝘯𝘦 𝘰𝘧 𝘵𝘩𝘦 𝘧𝘰𝘭𝘭𝘰𝘸𝘪𝘯𝘨): - Roundtable Discussion: Infrastructure As Code - Roundtable Discussion: Evolving Guidance on Laboratory Instruments - GAMP Basics: Periodic Validation Review - Panel Discussion – AI – Do You Know Where It Is Being Used and What For? - CyberSecurity - Good Practice Guide Update including alignment with GAMP 5, 2nd Edition - Regulatory Intelligence - Q&A and Chair’s Close As always, there are opportunities for people to network, interact, share stories and information (𝘳𝘦𝘨𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯, 𝘤𝘰𝘧𝘧𝘦𝘦 𝘣𝘳𝘦𝘢𝘬𝘴 𝘢𝘯𝘥 𝘭𝘶𝘯𝘤𝘩). Looking forward to renewing friendships and sharing regulatory news........ https://lnkd.in/dQsnEca4
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Struggling with communication breakdowns and inefficient workflows when working with Contract Research Organizations (CROs) for #drugdevelopment? This is a common problem. In this Teach Me in 10, we explore those pain points and introduce how Signals Synergy can improve communication and enhance data security. http://ms.spr.ly/6042YQJk4 The Teach Me in 10 is based off our DDW webinar.
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Ensuring robust data integrity, traceability, and compliance is critical for regulatory submissions in life sciences. Mareana Connect™ integrates data governance, security, and compliance measures to help organizations stay prepared for both US FDA and International regulatory requirements. Read the full Whitepaper here: https://lnkd.in/gSaV3WrT
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Webinar (28 May 2024) > EU-IVDR two years on. Understanding and effectively using the @IVDR transition for successful CE marking (webinar) > On 26th May 2022, the IVDR came into force and has been active for two years. At the beginning of this year, the European Commission took further steps to ensure the availability of certain IVDs, accelerating the sector’s progress towards the transition. Sue Spencer always refers to the consequences of ‘Taking your foot off the gas’, now she will talk about ‘Time to change gear’. What have we learned from the IVDR, and what real-world experience have we accumulated and how can we ally this to make the best use of the transition. What are the opportunities and what are the threats. More information & registration > https://lnkd.in/gMaCGVsu Qserve Group #labonchip
Free Webinar | EU-IVDR two years on. Understanding and effectively using the IVDR transition for successful CE marking
qservegroup.com
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🌟 New Blog Post Alert! What’s the Difference Between a DAKKS and NIST Certificate? 🌟 At Easylab webshop, we’re committed to helping you stay informed about the latest in laboratory standards and certifications. Our latest blog post dives into the key differences between DAKKS and NIST certificates. Here’s why you should check it out: 🔍 Understand the Standards: Learn about DAKKS (German Accreditation Body) and NIST (National Institute of Standards and Technology) and what sets them apart in terms of calibration and certification. 🌐 Global vs. National Recognition: Discover how DAKKS is recognized internationally and how NIST is crucial for U.S.-based compliance, helping you choose the right certification for your needs. 📏 Accuracy and Reliability: Find out how each certification ensures the accuracy and reliability of your laboratory equipment, ensuring you meet the highest standards of quality and precision. 🔧 Application and Compliance: Understand the specific applications and compliance requirements for each certification, so you can make informed decisions for your lab operations. Stay ahead in the world of laboratory equipment by understanding these critical certifications. Read our blog now and make sure your lab meets the right standards! 🔗 Read the Blog: https://lnkd.in/esAWmwEm #Easylab #DAKKS #NIST #LaboratoryStandards #Calibration #QualityControl #LabEquipment #Certification
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BSI Announces Support for IAF CertSearch - The First Global Database for Validating ISO Certs! STATEMENT FROM BSI Dated 1st November 2024 As your trusted partner, we want to keep you informed about updates to our certification services. The International Accreditation Forum (IAF) is a global association of accreditation bodies, industry representatives, and other organizations involved in conformity assessment. The IAF's main goal is to establish a worldwide conformity assessment program that reduces risk for businesses and customers. To further support this goal, the IAF has launched IAF CertSearch, an online database of accredited certifications. This platform helps users verify the validity of IAF accredited certifications, providing confidence and combating fraudulent claims. Users can search by certificate number or the registered name of the certified organization. As an IAF accredited Certification Body, BSI is required to provide and update data on our certified clients holding an IAF accredited certificate in the database. BSI certificates will be available on IAF CertSearch from 26th October 2024. The IAF has committed to adopting effective security standards and best practices to protect the information provided. The system does not contain the contact details of certified organizations. If you are interested in learning more about their security processes, please get in touch with them directly. IAF CertSearch is a valuable tool to assure your customers and stakeholders that your certification is valid. Additionally, you can always validate your certificate through our BSI Certification and Verification Directory available on the BSI website. We encourage you to use these resources to build trust and demonstrate conformity. For more details on IAF CertSearch, visit iafcertsearch.org. If you have any questions, please contact your local BSI office.
IAF Certification Validation - IAF CertSearch
iafcertsearch.org
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🌟 New Blog Post Alert! What’s the Difference Between a DAKKS and NIST Certificate? 🌟 At Easylab, we’re committed to helping you stay informed about the latest in laboratory standards and certifications. Our latest blog post dives into the key differences between DAKKS and NIST certificates. Here’s why you should check it out: 🔍 Understand the Standards: Learn about DAKKS (German Accreditation Body) and NIST (National Institute of Standards and Technology) and what sets them apart in terms of calibration and certification. 🌐 Global vs. National Recognition: Discover how DAKKS is recognized internationally and how NIST is crucial for U.S.-based compliance, helping you choose the right certification for your needs. 📏 Accuracy and Reliability: Find out how each certification ensures the accuracy and reliability of your laboratory equipment, ensuring you meet the highest standards of quality and precision. 🔧 Application and Compliance: Understand the specific applications and compliance requirements for each certification, so you can make informed decisions for your lab operations. Stay ahead in the world of laboratory equipment by understanding these critical certifications. Read our blog now and make sure your lab meets the right standards! 🔗 Read the Blog: https://lnkd.in/esAWmwEm #Easylab #DAKKS #NIST #LaboratoryStandards #Calibration #QualityControl #LabEquipment #Certification
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🌟 New Blog Post Alert! What’s the Difference Between a DAKKS and NIST Certificate? 🌟 At Easylab, we’re committed to helping you stay informed about the latest in laboratory standards and certifications. Our latest blog post dives into the key differences between DAKKS and NIST certificates. Here’s why you should check it out: 🔍 Understand the Standards: Learn about DAKKS (German Accreditation Body) and NIST (National Institute of Standards and Technology) and what sets them apart in terms of calibration and certification. 🌐 Global vs. National Recognition: Discover how DAKKS is recognized internationally and how NIST is crucial for U.S.-based compliance, helping you choose the right certification for your needs. 📏 Accuracy and Reliability: Find out how each certification ensures the accuracy and reliability of your laboratory equipment, ensuring you meet the highest standards of quality and precision. 🔧 Application and Compliance: Understand the specific applications and compliance requirements for each certification, so you can make informed decisions for your lab operations. Stay ahead in the world of laboratory equipment by understanding these critical certifications. Read our blog now and make sure your lab meets the right standards! 🔗 Read the Blog: https://lnkd.in/esAWmwEm #Easylab #DAKKS #NIST #LaboratoryStandards #Calibration #QualityControl #LabEquipment #Certification
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Companies spend billions of dollars a year on cybersecurity to assess and monitor risks, but pharma and biotech companies arguably have more to lose by failing to monitor referenced research. I recently sat in on a customer success meeting with a Research Solutions customer. We went over their article spend, usage, and collected feedback from the customer. What was different about this meeting is that we also performed a citation analysis for them showing which articles they were purchasing had been contrasted, corrected, or otherwise challenged. In some cases the articles they had purchased showed only minor differences between findings but in some cases there were strong refutations such as, “however, our study did not confirm these findings.” This information is critical to surface and can save lots of time, money, and effort. I will be talking about how this information can help researchers and organizations make sure they have the full picture at an upcoming webinar: https://lnkd.in/ePE94NhW. If you’d like to learn more, we’d be happy to run a free risk assessment for you! Just DM me and we can set up some time for a call.
Enhancing Research Efficiency with Smart Citations in iEnvision
researchsolutions.com
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In #research, we often see #citation counts, but just knowing how many times a paper or author was cited leaves a lot to be desired. It doesn't tell us how something was cited. A newer study might challenge the findings, or others may interpret the research differently, which can change the entire context when you have a #broader perspective you can make better decisions. Scite goes beyond simple citation counts to show the real conversation happening around millions of research. We're continuing this discussion in our live webinar, Enhancing Research Efficiency with Smart Citations in iEnvision, on Tuesday, September 10th at 10 am EST. Join us to dive deeper into how Smart Citations can streamline your research process.
Companies spend billions of dollars a year on cybersecurity to assess and monitor risks, but pharma and biotech companies arguably have more to lose by failing to monitor referenced research. I recently sat in on a customer success meeting with a Research Solutions customer. We went over their article spend, usage, and collected feedback from the customer. What was different about this meeting is that we also performed a citation analysis for them showing which articles they were purchasing had been contrasted, corrected, or otherwise challenged. In some cases the articles they had purchased showed only minor differences between findings but in some cases there were strong refutations such as, “however, our study did not confirm these findings.” This information is critical to surface and can save lots of time, money, and effort. I will be talking about how this information can help researchers and organizations make sure they have the full picture at an upcoming webinar: https://lnkd.in/ePE94NhW. If you’d like to learn more, we’d be happy to run a free risk assessment for you! Just DM me and we can set up some time for a call.
Enhancing Research Efficiency with Smart Citations in iEnvision
researchsolutions.com
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