Gregory Solz, RQAP-GCP, CQM, CQA

Curious about the ins and outs of testing for extractables and leachables? Discover the insights in Alcami Corporation's recent whitepaper by Chris Williams and Amanda Connor! With an arsenal of instrumentation that meets compliance standards and operates under cGMP regulations, the team at Alcami is poised to conduct precise trace analyses. These analyses are crucial for advancing your projects swiftly to market. This whitepaper sheds light on commonly asked questions such as: 🔷 The definition of extractables and leachables. 🔷 The origins of leachables. 🔷 Regulatory bodies' expectations. 🔷 Methods for identifying and measuring potential extractables and leachables. 🔷 Strategies for effective evaluation of extractables and leachables. Get your copy here ➡️ https://gag.gl/rtqmmj #CDMO #LabServices #AskAlcami #extractables #leachables #science

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Technology keeps advancing and so should your GXP application testing strategy.  With the move to the SaaS model manual testing following a script is not practical.  Automation will take over reducing time, effort while reducing risk and improving compliance. Let Lean Biologix show you how.

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Curious about the intricacies of extractables and leachables analysis? Discover the insights from Alcami Corporation's Chris Williams and Amanda Connor in their newly published whitepaper! Boasting an array of instruments that meet compliance standards and operating within cGMP protocols, Alcami's skilled team delivers prompt and precise trace analysis to expedite your product's journey to the marketplace. This whitepaper sheds light on common queries such as: 🔷 The definition of extractables & leachables 🔷 Origins of leachables 🔷 Guidelines set forth by regulatory bodies 🔷 Methods for identifying & measuring potential extractables & leachables 🔷 Strategies for effective evaluation of extractable and leachable substances Access it here ➡️ https://gag.gl/rtqmmj #CDMO #LabServices #AskAlcami #extractables #leachables #science

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At GxP Impact Consulting LLC., safety and community are core values in everything we do—including how we celebrate Halloween! One popular tradition we support is "Trunk-or-Treat," a safer and more convenient alternative to traditional trick-or-treating. Here’s why it’s a great option for families: Why Trunk-or-Treat? 1. Safety First: With a controlled, well-lit environment, kids can enjoy Halloween without worrying about busy streets or unsafe conditions. 2. Convenience: Everything happens in one spot, making it easier for parents and allowing children to collect candy more efficiently. 3. Community Spirit: These events bring neighbors, families, and friends together, fostering a sense of connection and shared fun. 4. Inclusivity for All: Perfect for younger children or those with mobility issues, plus many events offer allergy-friendly treats. 5. Extended Fun: It’s more than just candy! Enjoy games, contests, music, and creatively decorated trunks that make the experience interactive and exciting. Whether you're choosing traditional trick-or-treating or opting for Trunk-or-Treat, the most important thing is that everyone stays safe and has fun. Happy Halloween from GxP Impact Consulting! 🎃 #TrunkOrTreat #HalloweenSafety #Community #GxPImpact #SafetyMatters

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Take a look at the recent article, 'Biopharmaceutical Quality and Compliance: Navigating Good Manufacturing Practice Deviations’ published in BioProcess International, May 2024. Applied Biopharm Consulting offers experienced support for deviation investigations and meeting site KPIs. #qa #deviations #qms #quality #consulting

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🚀 Exciting Announcement 🚀 In the ever-evolving landscape of regulatory compliance, staying ahead is key. 💼✨ 🔍 Are you prepared to crusch your next FDA inspection? 🔍 In the upcoming days, we will dive into the crucial topic of utilizing industry data to fortify your company's readiness for an FDA inspection. 📊💡 Stay tuned for insights, strategies, and tips to navigate the intricacies of compliance seamlessly. Let's empower our teams to not just meet, but exceed regulatory expectations. 💪🏼💼 #FDAInspection #RegulatoryCompliance #Pharma #quality #FDAlytics

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📢 Exciting News for Pharma Professionals! 📢 For those who have been following our insights on pharmaceutical FDA observations, we have exciting news! 🎉 Starting soon, we will be diving even deeper into this critical topic through a series of blog posts on our website https://lnkd.in/eKgW-6gC. These blog posts will expand on the data and trends discussed in the LinkedIn posts, offering a more comprehensive analysis and practical insights for the industry. 🌟 All the data used in the LinkedIn posts has been sourced from the incredible FDAlytics. 📊 A link to their website in the comments below. Stay tuned for updates and be sure to check out the blog for in-depth content that can help you stay ahead in the pharmaceutical field! #Pharma #FDAObservations #FDAlytics #QualitySystems

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Discover prevalent calibration insights from the FDA, get ready for regulatory inspections, and boost your company's quality and safety standards with our new white paper! Prepare your team to remain compliant and thrive in regulated settings by: 🔷 Boosting precision and excellence 🔷 Minimizing hazards and enhancing safety 🔷 Gaining insights from actual data and outcomes Access the whitepaper here ➡️https://gag.gl/Su3OXD #FDA #Compliance #Calibration #QualityAssurance #auditready #alcaminow #metrology #scienceandtechnology

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Big News in the Gene Therapy World! Genezen is taking a huge step forward by acquiring uniQure’s gene therapy operations in Lexington, MA! This means they’re getting a new manufacturing facility and an amazing team, boosting their abilities from early development all the way to commercial manufacturing.🏭 Highlights: ✅ New strategic supply agreements for uniQure’s clinical projects and CSL’s HEMGENIX® – the first gene therapy for Hemophilia B approved in the US and Europe.🩸 ✅ The Lexington site will become Genezen’s global AAV center of excellence, joining forces with their Indianapolis team.🌍 ✅ Backed by extra funding from Ampersand Capital Partners, setting the stage for even more growth and innovation.💡 Steve Favaloro, Genezen’s CEO, is pumped about this acquisition, saying it perfectly aligns with their mission to push cell and gene therapies forward. Matthew Kapusta from uniQure and Michael Deem from CSL Behring are also excited about this new chapter. This is a major milestone in the gene therapy space, promising better manufacturing capabilities and support for cutting-edge treatments. #GeneTherapy https://lnkd.in/dnBtwKff

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#EnterpriseConnectAI Session Highlight: Discover how to foster an AI-driven environment, identify key stakeholders, and overcome challenges with Gary LaSasso, Sr Director, Global IT, Amicus Therapeutics. Don't miss his session at #EnterpriseConnectAI in Santa Clara this fall! Learn more: https://lnkd.in/e65Gqcxq #EnterpriseConnectAI #EnterpriseConnect #AI #ChatGPT #GenAI #GenerativeAI #EnterpriseAI #CXAI #LLMs #LargeLanguageModels #ArtificialIntelligence #Collaboration #Communications #cloud #CX #CustomerExperience #ContactCenter

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On-shoring has been discussed for the last 4-5 years as a growing concern in biotech. The Biosecure Act is counting down the clock now for a big change in how we do business. https://lnkd.in/e8DJHVs4

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I had a fine experience recently chatting with John "Barr" Weiner about the evolution and current state of combination product development, definition, and related regulatory considerations. From his continued tenure at FDA, in which he has served in various leadership roles, Barr brought to the latest conversation in my Sit and Deliver videocast series on @Drug Delivery Leader many illuminating perspectives on how stakeholding organizations in biopharma may want to approach the global regulatory arena for combination products. #drugdelivery, #combinationproducts, #medicaldevices, #fda https://lnkd.in/ee6Qyypp

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Let us know if you’re going to Asembia. We’d love to meet with you. #asembia24 #marketaccess  #analytics  #consulting  #communications  #pharma #payermarketing  #specialtypharmacy  #pharmacy  #pharmacists #engineeringtheartofaccess

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When it comes to drug testing, oral fluid testing offers a variety of advantages for employees and employers alike. In our upcoming webinar, Dr. Lance Presley, discipline director of forensic toxicology at Labcorp, will discuss these benefits and the future impact of the DOT’s new rule. Register here: https://lnkd.in/gd6b99Yi #OralFluid #DrugTesting #EmployeeDrugTesting

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As NAMs are becoming more relevant and accessible in today’s chemical product development, Labcorp is innovating in vitro alternatives so clients around the globe can leverage these new assays. From standard techniques to novel solutions, we can identify an approach that fits your product’s specific regulatory requirements. Discover your NAM options today. #CropProtection #ChemicalDevelopment #InVitroStudyAlternatives NewApproachMethodologies #NAMs

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