M. Brandon Means

🔧 Master CAPA Systems for Quality Excellence! Are your Corrective and Preventative Action (CAPA) systems as effective as they should be? This course is your opportunity to: ✅ Understand CAPA processes and their critical role in quality management ✅ Learn how to identify root causes and implement effective solutions ✅ Enhance compliance and prevent recurring issues Don’t miss this chance to improve your organization’s CAPA systems and drive quality improvements. 📅 Seats are filling fast—book your place now! https://lnkd.in/e_MAEYGW #CAPATraining #QualityManagement #ProfessionalDevelopment #Compliance #RootCauseAnalysis

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Create your own educational journey with the RAPS Regulatory Affairs Certificate Program. Through a series of courses, you can craft a professional development plan that fits your budget and your busy work schedule. Explore topics like medical devices, pharmaceuticals, quality and clinical. As 2024 comes to an end, it's a good time to map out your 2025 professional goals. Learn more about this popular program today: https://hubs.la/Q02_pQtq0

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Is it time to re-evaluate your CAPA processes? If your CAPA management isn't up to par, you could get cited by the FDA. Inefficient CAPAs are one of the most common reasons companies receive Warning Letters. Take a look at these strategies for ensuring you have successful CAPA management. Audit your CAPA process with OQSIE. Contact us for a free quote: www.oqsie.com/contact #capa #lifesciences #qualitymanagement

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🗝OUT NOW in the JMDR May 2024 issue: 🗝US FDA finalises rule incorporating ISO 13485 into new Quality Management System Regulation (QMSR) Are you aware of the revisions in the FDA’s Quality System requirements for medical devices? This new article from GlobalRegulatoryPress.com will help you understand: 🗝the content of the QMSR 🗝key differences between the QSR and QMSR 🗝and steps that manufacturers should take to prepare for implementation of the QMSR. by Pamela Forrest and Amy Leiser https://lnkd.in/dKNMZZNy #regulatoryaffairs #medicaldevices #samd #medizinprodukte #dispositivimedici #dispositifsmedicaux #dispositivosmedicos

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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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FDA recalls have significantly increased over the last six years and the 🔑 to avoiding one is staying on top of quality management. Learn more about some key components of product recall avoidance in MasterControl's guide here: https://lnkd.in/e_ZhWVxr #drugrecalls #qualitymanagement #lifesciences #FDA

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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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🖥️ Simplified Steps for SaMD Registration 🚀 Navigating compliance for Software as a Medical Device (SaMD) made easy: 1️⃣ Verify Qualification 2️⃣ Classify Software Risk 3️⃣ Research Regional Regulations 4️⃣ Implement a QMS 5️⃣ Create Technical Docs 6️⃣ Perform Validation Tests 7️⃣ Prepare Compliant Labeling 8️⃣ Submit for Regulatory Approval 9️⃣ Launch with Confidence 🔟 Maintain Post-Market Surveillance Stay ahead with these steps to ensure your software is market-ready✨ #SaMD #MedicalSoftware #ComplianceMadeEasy #RegulatoryAffairs #omcmedical

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Is your organization ready for an FDA inspection? FDA inspections can be stressful, but with proper preparation, you can navigate them successfully. NPG's latest white paper, "FDA Inspection Scramble: Is Your Organization Ready?" provides practical steps and insights to help you prepare effectively and avoid the last-minute scramble.   🔍 Understand the structure and purpose of FDA inspections.  🔍 Learn what to expect during and after an audit.  🔍 Discover practical strategies for inspection readiness.   Download your copy today and ensure your organization is always inspection-ready! Click the link to download: https://lnkd.in/eea9MY3g   #FDAInspection #Compliance #QualityAssurance #Pharmaceuticals #MedicalDevices #InspectionReadiness #NetworkPartnersGroup

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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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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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👉 #LifeSciences Quality and Compliance Professionals: Do you ever wish it was easier to make the business case for investing in a Quality Culture? Don't miss what is sure to be an actionable discussion with former FDA Investigator and current CREO Director of Quality and Regulatory Services, Vincent F. Cafiso, on how to calculate the cost of quality in life sciences. Register here: https://hubs.la/Q02M7h380 #qualityassurance

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Ever close a CAPA and then... surprise! The issue pops up again like it never left. 💀🖥️ 𝐂𝐀𝐏𝐀: 1, 𝐔𝐬: 0 😂 #QualityManagement #CAPA #RegulatoryAffairs #MedicalDevices #ContinuousImprovement #ProcessImprovement #QualityAssurance #QMS #Compliance #ProblemSolving #RiskManagement #ISO13485 #RootCauseAnalysis #Audit #MedicalDeviceManufacturing #QualityControl"

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How to avoid critical observations during regulatory inspections/audits? ▶️ One of the most critical findings reported by regulatory inspectors is the lack of a formal QMS or missing SOPs for critical processes. These gaps can severely compromise compliance and operational integrity in clinical research. ✔️ This ICUV model can help you stay on track: 🔢 𝗜nitiate the set-up early 🔢 𝗖over all critical processes 🔢 𝗨pdate your controlled documents regularly 🔢 𝗩ersion control and revision history must be included Does your QMS include these essential components? #clinicalresearch #qualitymanagement #qualitycultivator

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