Samir Ghevariya, MS, MBA, RAC (Devices)

PI's Krystal Santiago (VP Regulatory Affairs) discusses the shift towards point-of-care diagnostics and its drive to reduce test times while meeting stringent regulatory standards. Learn more about PI's regulatory expertise here: https://lnkd.in/dZKT6g2n #FDA #productdevelopment #regulatoryadvice #regulatorystrategy #regulatorystandards

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Wondering what are the different types of 510(k) submissions as per the FDA? Here, we have listed all three types of 510(k) submissions: 1. Special 510(k) 2. Abbreviated 510(k) 3. Traditional 510(k) Learn everything about them here. #510k #fda #medicaldevice #medicaldevices #medicaldevicecompanies #medicaldeviceregulations #fda510k #510ksubmission #regulatoryrequirements

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New draft guidance from FDA on defining and reporting protocol deviations. FDA regulations do not currently include a definition of the term protocol deviation or provide a system for classifying the various types of deviations that may occur during the conduct of a clinical investigation. This guidance may move industry closer to a system that applies consistent classification, reporting, and documentation standards is important to assure the most interpretable and useful information emerges from the reporting of protocol deviations. Open comment period through February 2025 for Sponsors, investigators and IRBs. Let your voice be heard! #clinicalstudies #clinicaltrials #pharma #clinicalresearch #biopharma https://lnkd.in/gWE_v5xx

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revelation by FDA A warning letter breakdown and Big learnings for all manufacturers. “Another day—another quite concerning warning letter. This one from a facility in India outlines critical CGMP deficiencies. • "Interviews with the sole analyst that is trained for sterility testing revealed that it is his routine practice to not test all batches for sterility and fabricate records for those samples not tested." • "Interviews with your microbiology staff revealed that it is their routine practice to fabricate records and results for samples that were not taken." • "Operators touching the inside of empty sterile tubes, prior to loading onto the filling line... Operators in the ISO 5 area leaning their head and torso over the bulk drug product [product] to manually check the fill level of the sterile bulk drug product." Some of the deficiencies at a glance: 🚩 Sterility samples missing from incubation. 🚩 Analyst routine practice of not testing all batches for sterility and fabricating records. 🚩 Environmental and personnel monitoring samples not collected as required. 🚩 Method validation not performed for all formulations. 🚩 Multiple steps or materials used in sterility testing not included in the initial validation. 🚩 Operators touching the inside of sterile tubes, leaning over filling lines, and exposing skin in ISO 5 areas. 🚩 Inadequate gowning practices, including stained and torn garments. The list goes on. ——— A few lessons here: ▪ Conduct regular audits and install automated systems to prevent data fabrication. Train analysts to understand the importance of complete and honest data recording. ▪ Make sure you have a robust environmental monitoring plan with defined sampling locations and frequencies. Implement real-time monitoring systems and cross-check records against physical samples regularly. ▪ Conduct thorough validation studies for each formulation, including all materials and steps used in the testing process. Regularly review and update validation protocols to address any discrepancies or changes in processes. ▪ Establish detailed gowning procedures, including regular inspections and replacements for damaged garments. Validate cleaning procedures with worst-case scenarios and ensure all equipment parts that contact sterile products are adequately sanitized. #fda #gmp #cgmp #pharmaceuticalmanufacturing

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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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🎉 I'm happy to share that I obtained the RCC-MDR certification from Regulatory Affairs Professionals Society (RAPS). The #MDR holds a special place in my heart and has been a major focus of my regulatory career over the last 5 years. 💡 RCC Facts: The Regulatory Compliance Certification (RCC) is a leading credential for #regulatory professionals in the #healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Success on the RCC exam requires knowledge of: ✅ Conformity of the Devices 📃 Technical Documentation 🔎 Post-marketing Surveillance ⚖ Vigilance 🔬 Clinical Investigations 

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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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😵‍💫 FDA (510k,PMA, de Novo) versus EU MDR notable differences or not the same. Here is our list of FAQ to help you explore the differences between the jurisdictions and conformity routes. #MedTechclearance #Medtech #FDA

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The transition to a Quality Management System Regulation (#QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on, write Jayet Moon and Arun Mathew in this new Drug Delivery Leader / Med Device Online article. https://lnkd.in/eEbJji4t #medicaldevices #designcontrols #regulatorycompliance #qms

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💲 FDA recently updated user fees for FY 2025 under MDUFA V. Get the highlights from Audrey Skeen on IVDwise. If you haven't yet, subscribe to IVDwise for Regulatory, Quality, and Clinical Insights for IVDs. #FDA #IVD #MedicalDevices #RegulatoryAffairs #CRO #IVDwise

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𝗔𝗻 𝗢𝘃𝗲𝗿𝘃𝗶𝗲𝘄 𝗼𝗳 𝗖𝗵𝗲𝗺𝗶𝗰𝗮𝗹 𝗖𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 Explore the intricacies of medical device materials in this technical brief by EVP & GM of Jordi Labs, Kevin Rowland. You'll learn why why robust chemical characterization is vital for patient safety and regulatory compliance. 🧪 ISO 10993 Standards: Ensuring biocompatibility and safe use. 🔍 Extractables & Leachables: Identifying potential risks. ⚠️ Toxicological Risk Assessment: From hazard to risk characterization. 🧬 Biological Equivalence: Leveraging existing data for new devices. Navigate the complexities of chemical characterization to enhance device reliability and efficacy. Read the full technical brief to understand how RQM+ can guide you through these critical processes. 🔗 https://lnkd.in/ecEBwyew

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📝📝Terminologies used for medical devices regulatory pathway by US FDA📝📝 Class I: Device Listed Class II: 510k Cleared Class III: Device Approved De Nova Request: Granted Make sure to use the right terminologies or it can lead to confusions and accuracies. #medicaldevices #regulatory #submissions #usfda #medtech #healthcare #devices #medicines #approval #process #regulatoryaffairs.

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An important document to mentionen from Nidhi Shah about Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool Second Edition. Please check out the link. https://lnkd.in/d3p8jxm3

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📌 What’s New? As part of the FY 2023 Omnibus Act, the FDA updated its guidance to include the 506J Device List, identifying devices subject to these reporting requirements. The FDA also encourages voluntary notifications to help prevent shortages. But What is 506J? Section 506J of the FD&C Act empowers the FDA to address potential medical device shortages during or ahead of public health emergencies. It requires manufacturers of certain devices to notify the FDA about production disruptions that could impact supply. 💡 Takeaway: If your device is on the 506J Device List, you must notify the FDA about any production issues. Stay informed and check the list to ensure compliance. For more details, see the updated 506J guidance!

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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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🔎 Internal QMS Audits under the QMSR 🔍   Medical device companies that need to transition to the QMSR and are not currently following ISO 13485 could have significant gaps in their QMS. Requirements for internal auditing are substantially similar, with some additional requirements under ISO 13485 A comprehensive QMSR Gap Analysis Checklist is available for download to identify potential QMS gaps.  https://lnkd.in/gSbjhEnN Includes transition support documents to help understand potential gaps and changes to meet the QMSR. After downloading the QMSR Checklist, you will receive these documents by email: 📗 QMSR Introduction & ISO 13485:2016 Requirements, 📗 QMSR Transition Guidance Manuals 📗 QMSR Transition Planning Form Templates Link to Blog: Best Practices for Internal Audits: https://lnkd.in/g3SFxuTR #iso13485 #qualitymanagement  #qualityconsulting #qmsinternalaudits

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Struggling with PFAS compliance in medical devices? It's a common challenge as regulations tighten. Dive into our whitepaper to discover the latest strategies for navigating these regulations and ensuring your products meet the highest standards. https://lnkd.in/gfaixBYk Download now and transform compliance into your competitive advantage! #TataElxsi #PFASRegulations #RegulatoryCompliance #MedicalDeviceCompliance #HealthTech

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