GxP-CC

We’re excited to participate in the PDA/FDA Joint Regulatory Conference. Our partner, Ulrich Köllisch, will co-lead an Interest Group session with Kir Henrici. This interactive session will focus on the latest developments in Data Integrity and Data Governance. We’ll explore potentials and challenges, guided by your questions and comments. Why This Matters to You: 🔹 Stay Informed: Get the latest insights on Data Integrity and Data Governance 🔹Interactive Learning: Engage directly with experts and peers 🔹Address Your Concerns: Shape the discussion with your questions Join us to enhance your knowledge and address your data challenges effectively. Register now: https://lnkd.in/eWX6nUYA #PDA #Learning #DataIntegrity #DataGovernance

📢 Webinar-Ankündigung - ALPHATOPICS GmbH📢 Entdecken Sie das Potenzial von KI und ML in der pharmazeutischen Industrie!: GMP-konforme Implementierung von KI/ML-Modellen 💊 Unser Partner Ulrich Köllisch gibt Einblicke in die neuesten Entwicklungen und Leitlinien von FDA und EMA, und wie diese Technologien bereits in der GMP-Herstellung und im Qualitätsmanagement genutzt werden. 🔍 Highlights: 🔹 Praktische Vorschläge für eine konforme Implementierung von KI/ML 🔹 Stärkung von Datenmanagementprogrammen 🔹 Entwicklung interner KI/ML-Standards 🔹 Fallstudien und Beispiele zur Risikokategorisierung gemäß ICH Q9-Prinzipien Erfahren Sie, wie KI und ML wiederholende Aufgaben übernehmen und hochqualifiziertes Personal entlasten können. Nehmen Sie teil und bleiben Sie an der Spitze der Innovation! 👉 Jetzt anmelden: https://lnkd.in/d9GyT6Pq #Pharma #KI #ML #Webinar #GMP #Qualitätsmanagement

🚀 Elevate Your Career! 🚀 Are you ready to take your career to new heights? Look no further! We're excited to announce an opening for a Senior Consultant within our vibrant team, based in Kaiserslautern, Germany. And here's the kicker – regardless of where you reside in Germany, remote work is fully embraced! 💼✨ Why Us? At GxP-CC , we're industry leaders in Life Science & Healthcare, driving change with 28 years of experience and a diverse team. 💡🌱 Why Join Us? We offer more than just a job – a rewarding career path with growth, competitive pay, comprehensive training initiatives, and a supportive work culture. At GxP-CC, your triumphs are our triumphs, and we're dedicated to fostering your success.📈💼 Ready to Apply? Seize this opportunity now! Apply here: https://lnkd.in/e7SDpp6Q Don't merely dream about your future – shape it with us. Join our team today, and let's craft something extraordinary together! ✨ #Hiring #Apply #JoinOurTeam #GxPCC

📢 Repost: "Harnessing Explainable AI in Life Sciences"!📢 Explainable AI (XAI) is a game-changer for the life sciences, offering crucial transparency and insight into AI decision-making processes. As AI advances in clinical research, medical practice, and patient care, XAI helps demystify the "black box" by clarifying how AI models make predictions. 🤖 Key methods include: 🔹 Feature Importance 🔹 Visualization Techniques 🔹 Attention Mechanisms These enhance understanding and trust in AI outcomes. Integrating domain-specific knowledge refines these models, accelerating breakthroughs in personalized medicine and drug discovery. 💊 With the new EU AI Act emphasizing transparency and human oversight, XAI is vital for ethical AI use and regulatory compliance. It’s driving innovation from drug repurposing to rare disease diagnostics.💡 👉 Read the full article here: https://lnkd.in/eEgTqvmY #ExplainableAI #LifeSciences #AI #Innovation #RegulatoryCompliance #Healthcare

📢 Poll Time: Our Repost-series comes to an end!📢 Our ICH Q9 (R1) (repost) blog series has come to an end! We've explored critical topics like formalizing QRM, making risk-based decisions, managing subjectivity, and tackling product availability risks. Now, we want to hear from you! Which key topic from our ICH Q9 (R1) blog series do you think is the most relevant one? 👉 Vote in the poll below and let us know which topic resonated with you the most! Thank you for joining us on this journey to better understand and apply the ICH Q9 (R1) guideline. If you missed any of the posts, you can still catch up on all the insights on our homepage. 🌟 Catch up if you’ve missed any part of the series!: Part 1: https://lnkd.in/ezmiGCs7 Part 2: https://lnkd.in/eeyH-r-i Part 3: https://lnkd.in/eQKapfQD Part 4: https://lnkd.in/e83S39wW #QRM #ICHQ9 #QualityManagement #Pharmaceuticals #RiskManagement

⏰ Reminder ⏰ Join our exclusive Data Integrity Workshop! Are you looking to enhance your organization's data integrity practices and ensure a culture of quality? Look no further! Our comprehensive workshop covers critical topics such as Data Integrity, Data Governance, Quality Culture, Access Control, Data and Audit Trail review strategy, and the exciting future of transitioning from Data Integrity to Quality Intelligence. Read more: https://lnkd.in/eXR3kaxk #dataintegrity #quality #audit #accesscontrol

📢Repost: Blog Post on Our Homepage: "Part 4: Addressing Product Availability Risks"!📢 Thaleia Papadopoulou, PhD, Senior Consultant at GxP-CC -CC, tackles the critical issue of product availability risks as part of the ICH Q9 (R1) series. Learn how proactive, risk-based strategies can prevent drug shortages and ensure continuous product supply by focusing on: 🔹Managing process variability and maintaining state control 🔹 Ensuring facilities and equipment meet stringent standards 🔹 Overseeing supplier activities effectively Discover how these strategies not only protect patient safety but also enhance overall drug availability. Don’t miss this crucial read for anyone involved in pharmaceutical manufacturing and quality management. 👉 Read the full article here: https://lnkd.in/e83S39wW #DrugShortages #RiskManagement #QRM #PharmaceuticalQuality #ICHQ9 #GxPCC #ProductAvailability

🚀 Elevate Your Career! 🚀 Are you ready to take your career to new heights? Look no further! We're excited to announce an opening for a Senior Consultant within our vibrant team, based in Kaiserslautern, Germany. And here's the kicker – regardless of where you reside in Germany, remote work is fully embraced! 💼✨ Why Us? At GxP-CC , we're industry leaders in Life Science & Healthcare, driving change with 28 years of experience and a diverse team. 💡🌱 Why Join Us? We offer more than just a job – a rewarding career path with growth, competitive pay, comprehensive training initiatives, and a supportive work culture. At GxP-CC, your triumphs are our triumphs, and we're dedicated to fostering your success.📈💼 Ready to Apply? Seize this opportunity now! Apply here: https://lnkd.in/e7SDpp6Q Don't merely dream about your future – shape it with us. Join our team today, and let's craft something extraordinary together! ✨ #Hiring #Apply #JoinOurTeam #GxPCC

📢Repost: Blog Post on Our Homepage: "Part 3: Managing and Minimizing Subjectivity"!📢 Thaleia Papadopoulou, PhD, Senior Consultant at GxP-CC , discusses the impact of subjectivity on Quality Risk Management (QRM) activities, highlighting its potential to influence product quality and patient safety. The revised ICH Q9 guideline addresses this issue extensively, noting that subjectivity can affect various QRM steps, such as risk assessment, hazard identification, and risk scoring. Understanding and managing subjectivity is crucial for minimizing its impact.🌟 Key insights include: 🔹Understanding factors like uncertainty and heuristics that contribute to subjectivity. 🔹The importance of knowledgeable QRM tool experts and skilled facilitators. 🔹Benefits of cross-functional teams in enhancing objectivity. 🔹Effective communication to ensure team focus and alignment. Don’t miss this essential read for optimizing your QRM processes and safeguarding product quality. 👉 Read the full article here: https://lnkd.in/eQKapfQD #QRM #RiskManagement #QualityControl #Pharmaceuticals #GxPCC #ICHQ9

Have you checked out our latest YouTube video? 📹 If you're seeking fresh inspiration and knowledge, you're in for a treat. Our channel is brimming with captivating and informative content that's bound to keep you engaged. 🌍 From thought-provoking discussions to handy how-to guides, there's something for everyone. 🎥 But don't just take my word for it – head over to our channel and dive into the fantastic content we've curated just for you! 🚀 So, what are you waiting for? Subscribe, hit the notification bell, and join our growing community of viewers on a journey of discovery. We can't wait to welcome you there! Check out our latest video now: https://lnkd.in/e2FRNBgr #YouTubeChannel #VideoContent #SubscribeNow #Inspiration