Sean Walsh

We live and breathe regulatory compliance. Azzur Group's GMP consultants are immersed in the standards set forth by the FDA, EMA, and other regulatory bodies including: ✅ 21 CFR Parts 11 and 820 ✅ FDA 2011 Process Validation Guideline ✅ Eudralex Volume 4 (EU cGMP Guideline) Have questions about your quality and compliance? Get your answers here: https://azzur.co/3xbIL8H #Compliance #GxPConsulting #LifeScience

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Documentation is key in demonstrating compliance in FDA-regulated fields. From URS to PQ and RTM, each type serves a crucial role! E2i's validation services help streamline this process, ensuring your systems meet industry standards and operate smoothly!

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Documentation is key in demonstrating compliance in FDA-regulated fields. From URS to PQ and RTM, each type serves a crucial role! E2i's validation services help streamline this process, ensuring your systems meet industry standards and operate smoothly!

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🗞 Breaking news 🤩 Genezen acquire uniQure's commercial GT manufacturing ops in Lexington!! This strategic acquisition will enable Genezen to deliver late-phase and commercial gene therapy development and manufacturing services to customers around the world. Check out full article below👇 #CDMO #Genezen #GeneTherapy

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Will we see more opportunity for Validation Professionals in 2025? The validation market is heating up as big players and industry shifts create new opportunities for CQV and Validation professionals. Here’s what’s driving the change: 📈 Biotech Expansion — With huge investments from Amgen ($1.5B), J&J ($2B), and Fujifilm Diosynth ($1.2B), demand for CQV engineers is set to rise. With many opportunities across Aseptic Processing, Equipment Validation and Automation. ⚙️ Tech-Enabled Validation — The shift to digital validation systems and paperless CQV is here. Companies are turning to cloud-based tools to streamline data capture and boost audit-readiness. 🌿 Sustainable Validation — As biopharma adopts green manufacturing, validation engineers must ensure compliance for eco-friendly production and energy-efficient systems. 💥 What’s Next? With 2025 a few weeks away I am looking to connect with CQV and Validation Consultants to discuss projects upcoming in Q1 next year. 👉 Do you think 2025 will have more opportunity that 2024? Let me know! #Validation #CQV #PharmaTrends #Biopharma #Innovation #AsepticProcessing #CellAndGeneTherapy #Sustainability

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Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities. 

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The FDA's Center for Drug Evaluation and Research has released its latest report on the state of pharmaceutical quality. This report is a comprehensive overview that sheds light on the agency's efforts to ensure the safety, efficacy, and quality of drugs available to patients. In the report you can find topics including: -Trends in manufacturing quality and compliance. -Efforts to modernize manufacturing technologies. -Strategies to address challenges in global drug supply chains. Check out the full report below #PharmaceuticalQuality | #FDA | #DrugSafety | #RegulatoryCompliance #Healthcare | #CDER | #QualityAssurance | #IndustryInsights

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Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities.

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Discover how Six Sigma transforms process validation for FDA compliance in our latest blog. Gain insights into effective strategies for life sciences companies to ensure product quality and operational efficiency. Read now for expert advice from...

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Unveiling FDA Trends! Discover the top Equipment Qualification observations of 2024. Sign up now at fdatracker.ai to know more!

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Attention Life Science Professionals! 🔥 ANOTHER HOT TOPIC ALERT! 🧪🔬 Some More Good News in the Life Sciences! Check out the summary below regarding the 3,000 jobs created in Boston area in 2024. Share your thoughts in the comments! And if you are looking for folks, please let us know! hashtag #lifesciences #biotech #pharma #medicaldevice #diagnostics #hiring2024 #boston The Richmond Group USA

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Did you catch the recent article authored by Anthony Newcombe? ‘Biopharmaceutical Quality and Compliance: Navigating Good Manufacturing Practice Deviations’ published in the May 2024 issue of BioProcess International. The article outlines key steps of a deviation management process, including impact assessments, root cause analysis, historical reviews and implementation of corrective and preventative actions (CAPAs). For on-site or remote support with timely management and closure of site deviations connect with Applied Biopharm Consulting. #deviations #gmp #qa #consulting #qms #compliance

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Like any executive, hiring a full-time quality Head of Quality can be expensive. Q&C services can fill VP of Quality and other GMP roles on a fractional basis, offering benefits such as https://lnkd.in/gmvS2VDi • Specialized skill sets: Save resources by acquiring precise skills when needed. • Instant availability & knowledge transfer: Avoid lengthy hiring cycles and benefit from transferred expertise, even after engagement ends. • Flexibility: Engage executives part-time or for specific projects, avoiding long-term commitments. • Scalability: Scale your business swiftly without the hiring process. • Cost-savings: Access high-level experience at a fraction of the cost. • Industry networks: Tap into extensive connections for expansion opportunities. • Objective insights: Gain fresh perspectives to uncover internal blind spots. See how Q&C services’ fractional Head of Quality can help scale your business. https://lnkd.in/gjtUuXi Click here to subscribe to our mailing list for Breaking News & Industry Insights: https://eepurl.com/hXy_Y9 #pharmaceutical, #gmp, #qualityassurance

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Like any executive, hiring a full-time quality Head of Quality can be expensive. Q&C services can fill VP of Quality and other GMP roles on a fractional basis, offering benefits such as https://lnkd.in/gmvS2VDi • Specialized skill sets: Save resources by acquiring precise skills when needed. • Instant availability & knowledge transfer: Avoid lengthy hiring cycles and benefit from transferred expertise, even after engagement ends. • Flexibility: Engage executives part-time or for specific projects, avoiding long-term commitments. • Scalability: Scale your business swiftly without the hiring process. • Cost-savings: Access high-level experience at a fraction of the cost. • Industry networks: Tap into extensive connections for expansion opportunities. • Objective insights: Gain fresh perspectives to uncover internal blind spots. See how Q&C services’ fractional Head of Quality can help scale your business. https://lnkd.in/gjtUuXi Click here to subscribe to our mailing list for Breaking News & Industry Insights: https://eepurl.com/hXy_Y9 #pharmaceutical, #gmp, #qualityassurance

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Like any executive, hiring a full-time quality Head of Quality can be expensive. Q&C services can fill VP of Quality and other GMP roles on a fractional basis, offering benefits such as https://lnkd.in/gmvS2VDi • Specialized skill sets: Save resources by acquiring precise skills when needed. • Instant availability & knowledge transfer: Avoid lengthy hiring cycles and benefit from transferred expertise, even after engagement ends. • Flexibility: Engage executives part-time or for specific projects, avoiding long-term commitments. • Scalability: Scale your business swiftly without the hiring process. • Cost-savings: Access high-level experience at a fraction of the cost. • Industry networks: Tap into extensive connections for expansion opportunities. • Objective insights: Gain fresh perspectives to uncover internal blind spots. See how Q&C services’ fractional Head of Quality can help scale your business. https://lnkd.in/gjtUuXi Click here to subscribe to our mailing list for Breaking News & Industry Insights: https://eepurl.com/hXy_Y9 #pharmaceutical, #gmp, #qualityassurance

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🌡️🛡️ ELPRO's GxP services team recommends temperature mapping during extreme summer months to avoid product degradation and ensure compliance with GDP and GMP guidelines. Here’s why it’s crucial: 1. Regulatory Compliance: Meet FDA and WHO guidelines with documented proof. 2. Risk Mitigation: Identify hot and cold spots to develop risk-avoidance strategies. 3. Improved Product Quality: Prevent spoilage and maintain high quality. 4. Cost Savings: Use resources and energy more efficiently. 5. Increased Customer Confidence: Provide proof of proper storage and transport. Ensure safety and compliance this summer with temperature mapping. Learn more: https://hubs.li/Q02yncyj0 #TemperatureMapping #Compliance #ProductQuality #RiskManagement #ELPRO

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FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

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