PharmaLex’s Post

Our on-demand webinar "SUMMER SHORTS: Risk-Based Quality Review: Inside Out" is now available for you to watch at your convenience, right from your desk! Discover how to balance risk vs. return in your Trial Master File with insights from our experts. Learn to navigate the often conflicting internal and external directives and find the right path for your organization. Watch now: https://lnkd.in/dDbCtPzS Rob Jones #Webinar #RiskBasedQuality #ClinicalDevelopment #TrialMasterFile #PharmaLex #QualityManagement #RegulatoryCompliance

Our on-demand webinar "SUMMER SHORTS: Risk-Based Quality Review: Inside Out" is now available for you to watch at your convenience, right from your desk! Discover how to balance risk vs. return in your Trial Master File with insights from our experts. Learn to navigate the often conflicting internal and external directives and find the right path for your organization. Watch now: https://lnkd.in/eitMzEsd #Webinar #OnDemand #RiskBasedQuality #ClinicalDevelopment #TrialMasterFile #PharmaLex #QualityManagement #RegulatoryCompliance

Struggling to stand out in the crowded lab market? Mark your calendars for next week's webinar! Discover how the Quality Control data you're already collecting can be your secret weapon! Join Polona Carson, a seasoned consultant from Neptune and Company, Inc., as she unveils practical strategies to analyze and present QC data. Transform your lab's approach to risk management, process optimization, and marketing. Why attend? ・Gain actionable insights from real laboratory examples. ・Learn to leverage QC data to not just participate but lead in the market. ・Engage directly with an industry expert and get your questions answered. 🔗 Secure your spot now: https://bit.ly/4flNCp8 Time is ticking, and seats are filling up fast. Don’t miss this opportunity to elevate your lab's competitive edge! #LabQualityControl #Webinar #CompetitiveAdvantage #LaboratoryExcellence #QualityData

Don't miss our upcoming 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝟮𝟬𝟮𝟰 – 𝗘𝗺𝗲𝗿𝗴𝗶𝗻𝗴 𝗧𝗿𝗲𝗻𝗱𝘀 𝗮𝗻𝗱 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗠𝗮𝗻𝗮𝗴𝗶𝗻𝗴 𝗥𝗶𝘀𝗸 webinar! Join us on 𝗧𝘂𝗲𝘀𝗱𝗮𝘆, 𝟭𝘀𝘁 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟮𝟬𝟮𝟰, 𝗳𝗿𝗼𝗺 𝟭-𝟮 𝗽𝗺 GMT to hear from industry experts Philip Jones and Richard Edwards MBA as they explore the latest trends and innovative approaches shaping the compliance landscape. ✅

𝐑𝐞𝐚𝐝𝐲 𝐭𝐨 𝐚𝐬𝐬𝐞𝐬𝐬 𝐭𝐡𝐞 𝐬𝐭𝐚𝐭𝐞 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 (𝐅𝐫𝐞𝐞)? 🧐 𝐖𝐞'𝐯𝐞 𝐠𝐨𝐭 𝐲𝐨𝐮 𝐜𝐨𝐯𝐞𝐫𝐞𝐝! ✅ ⮱ Maintaining well-managed, accurate, consistent, and reliable data in the life science industry is crucial for ensuring the efficiency and safety of your products. ⮱ 𝐓𝐡𝐚𝐭’𝐬 𝐰𝐡𝐲 𝐰𝐞’𝐯𝐞 𝐝𝐞𝐯𝐞𝐥𝐨𝐩𝐞𝐝 𝐚 𝐐𝐮𝐢𝐜𝐤 𝐚𝐧𝐝 𝐅𝐫𝐞𝐞 𝐃𝐚𝐭𝐚 𝐈𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭! By taking the assessment, you will be able to identify and evaluate gaps, gain actionable insights, align with regulatory requirements, and streamline your processes. ⮱ 𝐑𝐞𝐚𝐝𝐲?! >>>>> 𝐆𝐨! 🚀 🔗 https://hubs.ly/Q02GKXCK0 #Dataintegrity #DIassessment #LifeSciences #Compliance #DataManagement #PQEGroup

Consider this scenario: A routine process fails, and a company loses a key client overnight. They patch up the issue and move on, only for the same problem to resurface six months later, this time costing them millions. Why? Because they never bothered to investigate the real reason it happened. This could happen to any business that overlooks the importance of root-cause analysis. It's not just about meeting regulatory standards; it's about protecting your bottom line. Without it, you're flying blind, hoping problems don’t repeat themselves — but they almost always do. In this Finvi-sponsored webinar, a panel of experts will walk you through how to create a root-cause analysis program that not only addresses immediate issues but prevents them from coming back. Know exactly what to look for, how to fix it, and keep your business running smoothly. Don’t let one mistake become the domino that topples everything. Join us. 📌 How to Establish an Effective Root Cause Analysis Program 📅 Thursday, September 26 @ 1pm ET 🎙 Meet our speakers: Rozanne M. Andersen, Esq., Angie Erwin, CRCP, and Nicholas Prola 🔗 Register here: https://lnkd.in/eQjbMBxN #RootCauseAnalysis #BusinessResilience #Webinar

REGISTER FOR OUR BenefitMall JUNE 12th Compliance Webinar. Gain a comprehensive overview of the Patient-Centered Outcomes Research Institute Fee (PCORI), covering who pays the fees, how they're calculated, and essential filing deadlines. We'll also delve into the intricacies of 5500 requirements, including recent changes and best practices. https://lnkd.in/d_PyutpE

Get your regulatory guidance ready— Because we’re hitting the audit trail. 🗺️🥾 On this week’s episode of the State of TMF, Donatella and special host Aviv will guide you through how to plan and execute your own audit trail review. You’ll leave ready to breeze through your next audit trail review feeling inspection ready. Register now: https://lnkd.in/gZ8utqqd #eTMF #TMF #ClinicalResearch #ClinicalTrials

If you think that Audit Trail Review is not a requirement; if you think that Audit Trail Review is boring or if you just don't know what Audit Trail is...don't miss next episode 😁

Medicare Advantage organizations will be responding to more regulatory audits than ever in the coming year(s). Having a solid strategy and plan in place to respond to these audits is vitally important. Technology can help. Please join us on January 16th for a RISE sponsored webinar where we will be discussing how advanced technology can help your organization achieve the best validation rates possible. #oig #radv #compliance #audit