This week's QRx Partners Areas of Specialty Highlight - Regulatory Body Interaction Support ... 👉 "Leave the headaches of regulatory red tape to us! Our experts smooth the path with regulatory bodies, fast-tracking your clearance and approvals, and expediting the way for market success." Contact us any time to start the conversation: DM Christina Pecoraro or email [email protected]. Also, feel free to check out our library of videos on a variety of quality and regulatory topics on YouTube ▶ https://lnkd.in/gMjAKrTY #QRxPartners #QRxInforms #QRxSpecialties #MLV #regulatory #QualityLeadership #ComplianceTraining #MedTech #compliance #FDAcompliance #FDA #HereForYou
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QRx Partners knows that even planned interactions with regulatory bodies like FDA can seem daunting. They don't need to be. As with all things, planning and preparation are the key to smooth engagements and great results. QRx Partners has the experience to make planned interactions (pre-submission meetings, submissions, registration, etc.) a competitive advantage and guide your organization through the unplanned interactions (announced and unannounced inspections, official letters, etc.). Contact us today and let QRx Partners be your prescription for quality and regulatory success! #QRxPartners #QRxInforms #Quality #Regulatory #Consulting #FDA #MLV #Compliance
This week's QRx Partners Areas of Specialty Highlight - Regulatory Body Interaction Support ... 👉 "Leave the headaches of regulatory red tape to us! Our experts smooth the path with regulatory bodies, fast-tracking your clearance and approvals, and expediting the way for market success." Contact us any time to start the conversation: DM Christina Pecoraro or email [email protected]. Also, feel free to check out our library of videos on a variety of quality and regulatory topics on YouTube ▶ https://lnkd.in/gMjAKrTY #QRxPartners #QRxInforms #QRxSpecialties #MLV #regulatory #QualityLeadership #ComplianceTraining #MedTech #compliance #FDAcompliance #FDA #HereForYou
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🤔 Tell me the FDA doesn't trust your company without telling me. How about when a Warning Letter includes a detailed 11-point remediation plan for just one of the four violations covered by the letter (11 if you include the sub-topics)? Maybe it was because, during the inspection, employees openly admitted that they fabricated test records instead of performing the tests! 😳 They also admitted to ignoring the results of the tests and monitoring that were performed. ❗This doesn't just raise questions about data integrity but about organizational integrity as a whole. Talk about a lack of quality culture. The list of violations is much too long to summarize here, except to say that basically, any semblance of GMP controls were simply facades. Not surprisingly, the company's response to the Form 483 Inspectional Observations was deemed inadequate. Mostly because they focused only on vague future corrections without any indication of root cause identification nor any retrospective investigation of impacts on drugs already produced. We know that many of our readers only read our synopses, but this time, we encourage you to click on the link and read the entire Warning Letter. 👉 https://lnkd.in/g3_EVkUM Besides making you angry and maybe a little sick, it should be a strong reminder of why dotting i's and crossing t's is so crucial in the MedTech space. Being in quality or regulatory in MedTech requires strength, resolve, and ethics. And lest anyone think this is more of a problem for foreign manufacturers, as in this particular case, guess again. There are plenty of similar Warning Letters issued to U.S. companies. At some point, as a quality or regulatory professional, you need to be prepared to ask the hard question of whether this is a "hill" you're willing to "die" on. It can literally be a life-or-death decision—not for you but for all the patients placing their trust in the industry. Ultimately, there's no need to stand on that "hill" alone. Engaging outside experts like QRx Partners provides the additional "forces" and an unbiased voice that can tip the scales toward victory. #QRxPartners #QRxInforms #MLV #InadequateResponse #FDA #FDAcompliance #regulatory #CDER #pharma #HereForYou
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🚨 𝗗𝗼𝗻’𝘁 𝗥𝗶𝘀𝗸 𝗮 𝗟𝗮𝘀𝘁-𝗠𝗶𝗻𝘂𝘁𝗲 𝗥𝘂𝘀𝗵! 🚨 As a Notified Body according to #MDR and #IVDR, we understand the temptation for manufacturers to delay compliance activities, especially with recent deadline extensions. ⚠️ 𝘉𝘶𝘵 𝘣𝘦 𝘤𝘢𝘶𝘵𝘪𝘰𝘶𝘴 — these extensions aim to ease resource strain, not create a backlog! 📅 𝙒𝙖𝙞𝙩𝙞𝙣𝙜 𝙩𝙤 𝙨𝙪𝙗𝙢𝙞𝙩 𝙮𝙤𝙪𝙧 𝙘𝙤𝙣𝙛𝙤𝙧𝙢𝙞𝙩𝙮 𝙖𝙨𝙨𝙚𝙨𝙨𝙢𝙚𝙣𝙩? You're not alone. A last-minute wave of applications could overwhelm notified bodies, risking critical delays and potentially compromising your product’s market availability. 👋 If you have a legacy device and need conformity assessment, reach out to QMD Services today! Our team is ready to help you secure your product’s future on the European market. 👉 Don’t wait until it’s too late. Get in touch with QMD Services for a streamlined compliance journey. ➡️ This way to your application: https://lnkd.in/guyRxbyh 🙌 #Regulatory #Compliance #Transition #LegacyDevice #MedTech
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Learn why compliance with 21 CFR Part 58 is essential for ensuring the validity and acceptability of data submitted to regulatory agencies. RxCloud offers tailored audit solutions and expert guidance to navigate the complexities of GLP regulations with confidence. To know more visit www.therxcloud.com #GLP #RegulatoryCompliance #RxCloud #QualityAssurance
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🖋 This week's Inadequate Response appears to be another themed week for FDA Warning Letters, and according to three recently released warning letters, that theme is syringes. 💉 Two of them appear to be related, and the third indicates what appear to be common violations for this type of device. The connective tissue between these warning letters initially seems fairly clear but becomes muddied the more you try to follow the details. 💉 One organization appears to be the foreign manufacturer, and another is the specification developer and importer. When you look at the specific violations, they start with the manufacturer's lack of clearance or approval submissions, followed by a failure to resubmit upon making significant design and intended use changes. The third seemingly separate organization is cited for the same type of violations. 💉 Regardless of their connections, all three organizations made the same common mistake of assuming that 510(k) clearance is forever and somehow allows freedom to modify the device and its intended use without any regulatory burdens. 😳 💉 To us, one of the more subtle lessons here is that even when the device and its design are relatively simple, it is still possible to have changes that fit the FDA's definition of a significant change. 👉 Our theme, week after week, is once again that when you operate in the regulated space, you can't think that you understand your regulatory obligations; you must know them. As always, seeking expert guidance will be well worth the investment cost. 🤝 Let QRx Partners be your prescription for avoiding these regulatory "ailments". The three Warning Letters can be viewed below... 1️⃣ https://lnkd.in/gi-QR9_s 2️⃣ https://lnkd.in/gfqXz3SF 3️⃣ https://lnkd.in/gyzMTTpG #QRxPartners #QRxInforms #mlv #InadequateResponse #fda #fdacompliance #warningletters #cdrh #medicaldevices #compliance #regulatory #regulatorycompliance #experts
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In a world where regulatory compliance is crucial for success, Medfins International is here to guide you through every step. From securing your CDSCO License to achieving ISO 13485 certification and obtaining a Free Sale Certificate, we provide the expertise you need to thrive globally. Ready to elevate your compliance game and secure your future? Watch our latest reel to discover how we can help you navigate the complexities of medical regulations with confidence. 📞 Reach out to us at +91 7042028042 🌐 Learn more at https://lnkd.in/gitFwAyr #MedfinsInternational #MedicalCompliance #RegulatoryExcellence #GlobalMarkets #HealthcareInnovation #ComplianceJourney
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Ensuring DOT compliance is crucial for any business. That's why we're proud to offer the best service at low prices for DOT Drug and Alcohol tests, random consortium memberships, and a fully compliant program. Trust RPT Labs to keep your business safe and compliant. #DOTcompliance #drugtesting #safetyfirst #compliance #businesssolutions
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When it comes to regulatory compliance, 'close enough' isn't good enough. SeekrFlow's Sandbox allows enterprises to compare models side-by-side and determine which one provides accurate, compliant responses tailored to their use case. ➡ Example: We fine-tuned a model to CFR Title 21 (FDA regulations) to act as a regulatory assistant that guides users on compliance questions related to FDA standards. We compared its responses with a base model. We asked both: "What warning statements are mandated on the labels of feminine deodorant sprays?" ➡ Results: Fine-tuned model (left): Accurate, regulation-compliant response ✅ Base model (right): Inaccurate with irrelevant information ❌ In industries where compliance is non-negotiable, every response matters. Discover how SeekrFlow helps you meet regulatory standards with precision and confidence: https://bit.ly/40I9rKz
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🎙 Thank you Alexia Haralambous for highlighting the pain points of addressing inconsistencies in #FDA submissions. Are your submissions facing delays due to technical screening holds? 🌿 𝗧𝗶𝗺𝗲-𝗖𝗼𝗻𝘀𝘂𝗺𝗶𝗻𝗴 𝗙𝗶𝘅𝗲𝘀: Addressing inconsistencies often means updating internal quality documentation and resubmitting everything to the FDA. This can be a huge drain on time and resources. 🌿 𝗔𝗻𝗻𝗼𝘆𝗶𝗻𝗴 𝗛𝗼𝗹𝗱𝘀: Your hard work and sleepless nights can feel wasted when your submission is put on hold, delaying the entire process. 🌿 𝗘𝗳𝗳𝗼𝗿𝘁𝗹𝗲𝘀𝘀 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: With Fern.ai #SmartAuthoring, streamline content creation and management to minimize inconsistencies and maintain compliance effortlessly. Feel free to reach out for more insights on how #SmartAuthoring can address the pain points of your regulatory compliance process! 🌟 #RegulatoryCompliance #SmartAuthoring #Efficiency #MedTech #FernAI
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Are you planning on attending the upcoming Regulatory Affairs Professionals Society (RAPS) Convergence in Long Beach? Our valued QRx Partner, Mark Swanson, is, too, and would love to meet up! If you'd like to set up a time to chat with Mark while at the event, please click the link below! Calendar link 👉 https://lnkd.in/gnH6-pki RAPS event link 👉 https://lnkd.in/ghymP_Ac #QRxPartners #QRxInforms #MLV #RAPS #RAPSconvergence2024 #quality #regulatory #FDAcompliance #compliance #RegulatoryCompliance
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Improve Safety. Improve Outcomes with our Recall Sentry API. CEO/Founder @ Equiptrack®
2moA great value added service from QRx Partners .