KENX

Next Thursday - Don't miss this exciting complimentary webinar on reducing risk for staffing your GMP operations, presented by CAI's Harry Benson! Register now: https://lnkd.in/d-WKYMzT #GMP #Staffing #Freewebinar #webinar #lifescience #pharma

𝐊𝐄𝐘 𝐓𝐀𝐊𝐄𝐀𝐖𝐀𝐘𝐒! 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 & 𝐕𝐞𝐫𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐔𝐧𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲: 𝐔𝐧𝐥𝐨𝐜𝐤𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 Join us for a power-packed 3-day conference and training program focused on medical device validation and verification. Stay ahead with our comprehensive agenda covering Design & Development, Digitalization, Post Approval, and Compliance Intelligence across 4 dedicated tracks. Led by top industry and regulatory experts, explore the latest knowledge, best practices, and real-world case studies that drive success. Connect with peers, expand your network, and gain invaluable insights to elevate your professional journey. 𝐄𝐯𝐞𝐧𝐭 𝐃𝐞𝐭𝐚𝐢𝐥𝐬: 𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧: Chicago, Illinois 𝐃𝐚𝐭𝐞𝐬: September 17-19, 2024 𝐒𝐞𝐬𝐬𝐢𝐨𝐧𝐬: Over 30 led by seasoned professionals 𝐄𝐚𝐫𝐥𝐲 𝐁𝐢𝐫𝐝 𝐏𝐫𝐢𝐜𝐢𝐧𝐠: Available until August 9, 2024 Don’t miss this opportunity to advance your career in the dynamic field of medical device innovation. Secure your spot now! Link to register: https://lnkd.in/gdy9pavV #KeyTakeaways #MedicalDeviceValidation #VerificationUniversity #UnlockingTheFuture #ChicagoConference2024 #MedicalInnovation #MedTechTraining #ComplianceIntelligence #EarlyBirdPricing #NetworkAndLearn #IndustryExperts #ProfessionalDevelopment #MedicalDeviceConference Compliance Group Inc PQE Group FOCUS Laboratories ValGenesis VTI Life Sciences KPMG US Pat Baird Rucha Patel Luiz Alberto Barberini MSc CPIM CSCP CQE Ritam Priya Joscelyn Bowersock Dr. Radhika Ramachandran Taylor Dieringer Andrea Roether Joanne Goldberg Steve Silverman Donna-Bea Tillman Anthony Grilli Stephen Tyrpak Lacey Harbour Smith MS, RAC, MB(ASCP) Gaurav Walia Xenophon Papademetris Jessica Wilkerson Kalpesh Patel MBA, PMP, CSM David Vincent, CEO/ B.Sc., MPH, PhD Howard Wilensky John Kirchner Evan Haltzman Tracy

𝐒𝐀𝐕𝐄 𝐓𝐇𝐄 𝐃𝐀𝐓𝐄! 𝐂𝐒𝐕 & 𝐂𝐒𝐀 𝐔𝐧𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲: 𝐓𝐡𝐞 𝐏𝐫𝐞𝐦𝐢𝐞𝐫 𝐏𝐫𝐨𝐠𝐫𝐚𝐦 𝐟𝐨𝐫 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐏𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥𝐬 Join us at the largest and most comprehensive program dedicated to CSV, attracting 200-300 participants from the life science industry, including professionals in 𝐞𝐧𝐠𝐢𝐧𝐞𝐞𝐫𝐢𝐧𝐠, 𝐯𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧, 𝐪𝐮𝐚𝐥𝐢𝐭𝐲, 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭, 𝐈𝐓, 𝐚𝐧𝐝 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞. This multi-track conference features over 40 tutorials, providing a platform for exchanging best practices and addressing challenges such as 𝐝𝐢𝐠𝐢𝐭𝐚𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧, 𝐭𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥 𝐚𝐝𝐯𝐚𝐧𝐜𝐞𝐦𝐞𝐧𝐭𝐬, 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲, 𝐂𝐒𝐀, 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐭𝐡𝐢𝐧𝐤𝐢𝐧𝐠, 𝐫𝐢𝐬𝐤 𝐚𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭𝐬, and both evolving and traditional CSV trends. We will also explore emerging challenges like superintelligence governance, AI/ML, ChatGPT, and more. We anticipate a significant turnout this year due to new 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐚𝐧𝐝 𝐭𝐫𝐞𝐧𝐝𝐬 𝐢𝐧 𝐀𝐈/𝐌𝐋, 𝐂𝐒𝐀, and more. 𝐒𝐚𝐯𝐞 𝐭𝐡𝐞 𝐃𝐚𝐭𝐞: December 10-12, 2024 - Washington, DC. 𝐓𝐨 𝐫𝐞𝐠𝐢𝐬𝐭𝐞𝐫, 𝐜𝐥𝐢𝐜𝐤 𝐡𝐞𝐫𝐞: https://lnkd.in/grkH3mxN #CSVUniversity #CSAUniversity #IndustryProfessionals #LifeScienceIndustry #Engineering #Validation #QualityControl #SoftwareDevelopment #IT #RegulatoryCompliance #Digitalization #TechnologicalAdvancements #DataIntegrity #CriticalThinking #RiskAssessments #EmergingTrends #SuperintelligenceGovernance #AI #ML #ChatGPT #RegulatoryGuidance #CSATrends #ProfessionalDevelopment #LifeSciencesConference #CSVConference #IndustryBestPractices CAI ValGenesis Compliance Associates Compliance Group Inc Kneat Solutions KPMG US Massachusetts Technology Innovation Minerva PQE Group ProcellaRX, LLC Sagax Team VEQTOR VTI Life Sciences Zifo Howard Wilensky John Kirchner Evan Haltzman Tracy

𝐌𝐄𝐄𝐓 𝐓𝐇𝐄 𝐒𝐏𝐄𝐀𝐊𝐄𝐑𝐒! Join us at 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 & 𝐕𝐞𝐫𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐔𝐧𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲, a 3-day conference and training program in 𝐂𝐡𝐢𝐜𝐚𝐠𝐨 from 𝐒𝐞𝐩𝐭𝐞𝐦𝐛𝐞𝐫 17-19, 2024. Led by top industry and regulatory experts, the event features over 30 sessions covering 𝐃𝐞𝐬𝐢𝐠𝐧 & 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭, 𝐃𝐢𝐠𝐢𝐭𝐚𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧, 𝐏𝐨𝐬𝐭 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥, 𝐚𝐧𝐝 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞. Connect with peers, expand your network, and gain insights to elevate your career in medical device validation and verification. 𝑺𝒆𝒄𝒖𝒓𝒆 𝒚𝒐𝒖𝒓 𝒔𝒑𝒐𝒕 𝒏𝒐𝒘 𝒂𝒏𝒅 𝒆𝒏𝒋𝒐𝒚 𝒆𝒂𝒓𝒍𝒚 𝒃𝒊𝒓𝒅 𝒑𝒓𝒊𝒄𝒊𝒏𝒈 𝒖𝒏𝒕𝒊𝒍 𝑨𝒖𝒈𝒖𝒔𝒕 9, 2024! 𝑼𝒔𝒆 𝒕𝒉𝒆 𝒍𝒊𝒏𝒌 𝒕𝒐 𝒃𝒐𝒐𝒌 𝑬𝒂𝒓𝒍𝒚 𝑩𝒊𝒓𝒅 𝒕𝒊𝒄𝒌𝒆𝒕𝒔: https://lnkd.in/g47jetjh Xenophon Papademetris Pat Baird Rafael Padilla Kalpesh Patel MBA, PMP, CSM, Luiz Alberto Barberini MSc CPIM CSCP CQE Joanne Goldberg Lacey Harbour Smith MS, RAC, MB(ASCP) Rucha Patel Taylor Dieringer Joscelyn Bowersock Jessica Wilkerson Howard Wilensky John Kirchner Evan Haltzman Tracy

𝐄𝐥𝐞𝐯𝐚𝐭𝐞 𝐲𝐨𝐮𝐫 𝐜𝐥𝐞𝐚𝐧𝐫𝐨𝐨𝐦 𝐚𝐧𝐝 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐜𝐥𝐞𝐚𝐧𝐢𝐧𝐠 𝐞𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞 𝐚𝐭 𝐭𝐡𝐢𝐬 𝐜𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 3-𝐝𝐚𝐲 𝐜𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐢𝐧 𝐒𝐚𝐧 𝐃𝐢𝐞𝐠𝐨: 𝐂𝐥𝐞𝐚𝐧𝐫𝐨𝐨𝐦 𝐂𝐨𝐧𝐭𝐚𝐦𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐂𝐨𝐧𝐭𝐫𝐨𝐥 𝐄𝐧𝐯𝐢𝐫𝐨𝐧𝐦𝐞𝐧𝐭𝐚𝐥 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐂𝐥𝐞𝐚𝐧𝐢𝐧𝐠 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 This co-located event offers over 40 unique sessions, providing in-depth learning opportunities for both cleanroom control and cleaning validation professionals. 𝐊𝐞𝐲 𝐭𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬 𝐢𝐧𝐜𝐥𝐮𝐝𝐞: 1. Advancements in cleanroom technology, 2. Bridging the gap by aligning your processes to the Annex 1 update, 3. Harnessing generative AI for enhanced cleanroom validation, 4. Disinfection and environmental monitoring, 5. Performing facility Annex 1 compliance GAP analysis, 6. Developing and implementing a risk-based non-sterile program, 7. Navigating the barriers associated with implementing alternative microbiological methods, and many more. 𝐀𝐔𝐆𝐔𝐒𝐓 6-8, 2024  𝐒𝐚𝐧 𝐃𝐢𝐞𝐠𝐨, 𝐂𝐚𝐥𝐢𝐟𝐨𝐫𝐧𝐢𝐚  𝐇𝐢𝐥𝐭𝐨𝐧 𝐒𝐚𝐧 𝐃𝐢𝐞𝐠𝐨 𝐆𝐚𝐬𝐥𝐚𝐦𝐩 𝐐𝐮𝐚𝐫𝐭𝐞𝐫 Download the full brochure by clicking https://lnkd.in/gbEiEJHa Save your seat by clicking https://lnkd.in/g8U8sxDT #MasterCleanroom #ContaminationControl #EnvironmentalMonitoring #Conference #SanDiego #CleaningValidation #CleanroomExpertise #3DayEvent #Over40Sessions #AdvancementsInCleanroom #EmergingTrends #Annex1Update #GenerativeAI #EnhancedValidation #Disinfection #FacilityCompliance #RiskBasedPrograms #AlternativeMicrobiologicalMethods #SaveYourSeat CAI Microbiologics SherpaPharma FOCUS Laboratories Novatek International ValGenesis Quascenta Temple University Alexandra B. Anthony Grilli Joscelyn Bowersock Daniel Klein Dawn Marshall Liz Brockson, MPH-VPH Ravi Moorthy Cynthia Duhigg ASQ CSSBB, CQA Arielle Musa Christiana Ellis Ratul Saha, Ph.D. David Vincent, CEO/ B.Sc., MPH, PhD Neal Schmidt, MS, PMP Nathan Wasilko Donald Singer Michael Westerman Sharif Uddin Sheba Zaman Howard Wilensky John Kirchner Evan Haltzman Tracy

🌟 "Lean Validation: Journey of Elevating Your Processes with Computer Software Assurance and Digitalization" in Philadelphia from June 26-27! 🌟 In today’s rapidly evolving landscape, where the FDA’s new guidance and cutting-edge digital platforms, including generative AI, are shaping the future, it’s paramount to reassess your organization’s practices. Now is the time to modernize your processes for optimal efficiency and compliance. 🔑 A promise to explore the World of Possibilities with Over 15 Tutorials Covering Today’s Top Challenges: 𝐂𝐨𝐦𝐩𝐮𝐭𝐞𝐫 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐀𝐬𝐬𝐮𝐫𝐚𝐧𝐜𝐞 𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: -Conduct a Comprehensive Gap Analysis and Transition Seamlessly to CSA -Dive into Scripted and Unscripted Testing, Assessing Requirements and Criticality -Navigate Post-Transition Challenges: Training Programs, Change Control, Continuous Monitoring 𝐃𝐢𝐠𝐢𝐭𝐚𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐈𝐦𝐩𝐥𝐞𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧: -Embrace Human-Centered Design: The Soft Skills Essential for Successful Digitalization -Explore the Journey to a Paperless Environment: Case Studies and Best Practices -Harness the Power of Digital Threads and Ensure Data Integrity Governance -Innovative Approaches: Leveraging ChatGPT & Generative AI in Validation -Delve into Real-World Case Studies: Implementing Machine Learning and Digital Twins Here's a sneak peek of the event along with industry leaders who chose to be ahead and leverage the rich network with multiple learning options. Become our member to keep getting more updates on our upcoming conferences, and webinars with access to multiple articles and presentations! Membership Link: https://lnkd.in/giYXYDBU #LeanValidation #CSA #Digitalization #Validation #AI #FDA #PhiladelphiaEvent #Compliance #Innovation Howard Wilensky John Kirchner Evan Haltzman Tracy ValGenesis CAI Compliance Group Inc FOCUS Laboratories KPMG US Main and Mission TTC VTI Life Sciences

IMPORTANT UPDATE! Early bird pricing ends this Friday, June 28th—save $300 in total, including the discount code below! Don’t miss out on this multi-track event in San Diego, August 6-8, focusing on: Cleanroom Contamination Control & Disinfection Environmental Monitoring Program Design & Management Cleaning Validation & Critical Cleaning Processes Are you planning to attend? Here are the registration instructions and a special discount code for our valued KENX customers: 1. Navigate to this link: REGISTER HERE https://lnkd.in/g8U8sxDT 2. Click “Get Tickets” 3. Choose your ticket option Plus, take advantage of our team discount: Register 3, and the 4th attends free! Howard Wilensky John Kirchner Evan Haltzman Tracy ValGenesis CAI Microbiologics Quascenta SherpaPharma VTI Life Sciences

Today marks the conclusion of the three-day Lab University Conference in Philadelphia. Over these past days, attendees, sponsors, and speakers engaged in networking, gained the latest industry insights, and participated in enriching discussions and tutorials, all contributing to a broader knowledge base. We received valuable feedback regarding the format, discussion topics, and overall execution of the conference. KENX remains dedicated to fostering continuous knowledge exchange for all our partners and customers in an organized manner. Become a member at https://lnkd.in/giYXYDBU and connect with industry peers to enhance your learning and networking opportunities. For more information, contact us at [email protected] #lifesciences #validation #pharma4 #pharmaevent Howard Wilensky John Kirchner Evan Haltzman Tracy Julian Sanchez Compliance Group Inc FOCUS Laboratories H&A Scientific, Inc. Novatek International VTI Life Sciences

Day 2 of the Lab University Conference in Philadelphia organized by KENX has been bustling with visitors, meetings, tutorials, and some lively discussions over lunch. We've received excellent feedback from our visitors and partners on the quality of knowledge exchange, the opportunities to connect with industry leaders, and unparalleled insights on conference-related topics. Our goal is to keep our audience informed about industry developments and facilitate frequent connections. For more details on upcoming events, write to us at [email protected] or visit https://lnkd.in/giYXYDBU to become a valued member. #pharma #validation #compliance #stability #lifesciences #events Howard Wilensky John Kirchner Evan Haltzman Tracy Julian Sanchez Compliance Group Inc FOCUS Laboratories H&A Scientific, Inc. Novatek International VTI Life Sciences

KENX is thrilled to host the Lab University Conference from June 4-6 at Convene in Philadelphia. This event focuses on Analytical Method Development & Validation, Stability Testing, and QC Lab Management. Join industry leaders for in-depth discussions and tutorials. For more information, follow our page or contact us at [email protected] Howard Wilensky John Kirchner Evan Haltzman Tracy Compliance Group Inc FOCUS Laboratories H&A Scientific, Inc. Novatek International VTI Life Sciences #pharma #event #validation #philadelphia