Kelly Waldron, PhD, MBA

📢 Join the New England Regional Chapter of the Society of Quality Assurance (NERCSQA) for this week’s webinar, “Responsibilities of the Quality Control Unit”! 📢 🗓️ Date: Wednesday, 20 November 🕚 Time: 11:00 AM - 12:00 PM Eastern Standard Time Quality Control is at the heart of drug manufacturing, yet it remains a common area for noncompliance. In FY23, the FDA’s CDER Office of Compliance highlighted 21 CFR 211.22 as the most frequent citation in warning letters to drug manufacturing facilities. 🔍 Webinar Highlights: • Explore the deceptively simple yet critical requirements of 21 CFR 211.22 • Understand why "Responsibilities of quality control unit" remains the top-cited issue • Learn from recent FY23 case studies and gain insights into avoiding noncompliance This session will delve into the expectations for #qualitycontrol units and provide guidance on effectively overseeing drug manufacturing operations. 👉 Act quickly, and register here: https://bit.ly/40OImp7 #NERCSQA #QA #webinar

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Did you miss our latest blog outlining the differences between the new ICH M12 Guidelines and the 2020 FDA DDI Guidance? Read all about it here: https://hubs.ly/Q02DSm4M0 You can always browse our comprehensive catalogue of publications on our Science Pool: https://hubs.ly/Q02DSwXF0 Find everything you need in the Science Pool, including our webinars, case studies, posters and publications from across Evotec, Cyprotex, and Just Evotec Biologics. #Cyprotex #Pharma #DrugDevelopment #ClinicalResearch #ICHM12

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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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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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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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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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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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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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Preventing Contamination in Cosmetic Formulations: Ensuring Safety and Quality Contamination prevention is a critical aspect of cosmetic product formulation, ensuring the safety and quality of products for consumer use. Microbial contamination can lead to product spoilage, customer complaints, and even recalls. In this article, we'll explore strategies for preventing contamination in cosmetic formulations. Sources of Contamination 1. Raw materials 2. Water 3. Equipment 4. Personnel 5. Environment Prevention Measures 1. Raw Material Control: Verify supplier quality, test for microbiological purity, and store materials properly. 2. Good Manufacturing Practices (GMP): Implement cleanroom procedures, personnel training, and equipment sanitation. 3. Water Quality: Use purified water, monitor water quality, and implement water treatment systems. 4. Equipment Sanitization: Regularly clean and sanitize equipment, pipelines, and storage tanks. 5. Personnel Hygiene: Enforce handwashing, gloves, and clean uniforms. 6. Environmental Control: Maintain clean facilities, control temperature and humidity, and prevent pest infestations. Formulation Strategies 1. Preservative Systems: Effective preservatives prevent microbial growth. 2. pH Control: Maintain optimal pH levels to inhibit microbial growth. 3. Water Activity: Control water activity to prevent microbial growth. 4. Antimicrobial Agents: Incorporate antimicrobial agents, such as triclosan or phenoxyethanol. Testing and Quality Control 1. Microbiological Testing: Regularly test products for microbial contamination. 2. Stability Testing: Evaluate product stability and shelf-life. 3. Quality Control Checks: Monitor production processes and product quality. Best Practices 1. Training and Education: Educate personnel on contamination prevention. 2. Documentation: Maintain detailed records of production, testing, and quality control. 3. Continuous Improvement: Regularly review and update processes. By implementing these strategies, cosmetic manufacturers can ensure the safety and quality of their products, protecting consumers and maintaining brand reputation.

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FDA Final Rule Amending Quality Management System Regulation: - On January 31, 2024, the FDA issued a significant final rule amending the Quality Management System Regulation (QMSR), which aligns closely with ISO 13485:2016. Read the full article: https://lnkd.in/gzgNEd8D #regulatorycompliance #fdaapproval #fda

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Corrective and preventive action (#CAPA) processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement. https://lnkd.in/dDdYAXEP Cencora | Pharma solutions #QMS #clinicalresearch

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AAMI has officially released TIR48, a new guidance document that will help manufacturers navigate FDA's Current Good Manufacturing Practices (CGMPs) related to combination products. It addresses risk management, quality policy, inspection readiness, and compliance pathways for 21 CFR. Get the latest on the guidance and what these means for you! #medicaldevices #regulatorycompliance #combinationproducts https://lnkd.in/encewHfd

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The FDA has been rolling out changes with the new QMSR (Quality Management System Regulation), and there's been a lot of discussion around what it all means. If anyone still has questions, the 𝗙𝗗𝗔 𝗵𝗮𝘀 𝗷𝘂𝘀𝘁 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝘁𝗵𝗲𝗶𝗿 𝗙𝗔𝗤 on the topic to provide more clarity. You can check it out here: 👉 https://lnkd.in/e5N78dBs On top of that, for those looking to dive deeper into the differences between the old QSR and the new QMSR, 𝘄𝗲’𝘃𝗲 𝗴𝗼𝘁 𝗮 𝗱𝗲𝘁𝗮𝗶𝗹𝗲𝗱 𝗰𝗼𝗺𝗽𝗮𝗿𝗶𝘀𝗼𝗻 𝘁𝗮𝗯𝗹𝗲 available for download. It also highlights how ISO 13485 fits into the equation. 👉 https://lnkd.in/eESmKAtR Between these resources, you should have everything needed to stay on top of the latest regulatory updates! #FDA #QMSR #ISO13485 #RegulatoryUpdates #MedicalDevices

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🚨 New FDA Draft Guidance Alert! 🚨 The FDA has released a draft guidance document titled "Considerations for Complying with 21 CFR 211.110". This guidance provides crucial insights into ensuring batch uniformity and drug product integrity, especially for those utilizing advanced manufacturing techniques. 🔍 Key Highlights: Ensuring batch uniformity and drug product integrity Incorporating process models into commercial manufacturing control strategies Quality considerations for advanced manufacturing 📄 Read the Draft Guidance Document: https://lnkd.in/ei2GZv87 At MMS, we understand the complexities of regulatory compliance and are here to help you navigate these requirements seamlessly. Our team of experts can assist you in implementing the necessary controls and strategies to ensure compliance with 21 CFR 211.110. 💡 How MMS Can Help: Comprehensive compliance assessments Customized control strategy development Advanced manufacturing support Let's work together to ensure your manufacturing processes meet the highest standards of quality and compliance. Contact us today to learn more about how we can support your compliance journey! #FDA #Compliance #Pharmaceuticals #AdvancedManufacturing #QualityAssurance #OneMMS

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Get this practical guide to current GMP guidelines including EU GMP Annex 1. It starts by explaining the requirements, then breaks down what that means to you in your manufacturing facility. The book is broken into 3 sections: - fundamentals - applications - solutions. Get this e-book today: https://bit.ly/3qz4d4b

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