QRx Partners

When your medical technology company is just getting started, a complete QMS is not required, and the company certainly doesn't need a QMS that is complex and burdensome. QRx Partners understands that QMS implementation is an evolution from basic controls to eventual full compliance, and we're here to help. Contact us anytime to start a friendly, obligation-free conversation at contact@qrxpartners.com. Find us on YouTube 👉 https://lnkd.in/gMjAKrTY Our Website 👉 www.qrxpartners.com Check our street cred 👉 QRx Partners Steve Gompertz & Mark Swanson Let us help you start 2025 in compliance. 🤝 #QRxPartners #QRxInforms #MLV #QRxSpecialties #QMS #MedTech #compliance #FDAcompliance #regulatory #FDA #HereForYou

REMINDER! QRx Partner Steve Gompertz, in partnership with ComplianceQuest and Quality Digest, will present this free, informative one-hour webinar. Register now! Info & registration link 👉 https://lnkd.in/gEyX-G9j What You’ll Learn: ✔️ Auditors' true objectives and focus areas ✔️ Effective preparation techniques—beyond tidying your desk ✔️ How to avoid common audit pitfalls ✔️ Tips for better, active engagement with auditors #QRxPartners #QRxInforms #mlv #ComplianceQuest #QualityDigest #quality #regulatory #audits #auditor #compliance #FDAcompliance #AuditPrep #HereForYou

#MondayMotivation from the incomparable Coach John Wooden. We're here to help with your compliance (and more!) so you can focus on what you do best. 🤝 https://lnkd.in/gZ6nw-9M #QRxPartners #QRxInforms #MLV #wooden #compliance #regulatory #quality #FDAcompliance #MedTech #pharma #biologics #invitro #HereForYou

Clear your schedule on Tuesday for this free and informative 1-hour webinar presented by QRx Partner Steve Gompertz in partnership with ComplianceQuest and Quality Digest! Info & registration link 👉 https://lnkd.in/gEyX-G9j What You’ll Learn: ✔️ Auditors' true objectives and focus areas ✔️ Effective preparation techniques—beyond tidying your desk ✔️ How to avoid common audit pitfalls ✔️ Tips for better, active engagement with auditors #QRxPartners #QRxInforms #mlv #ComplianceQuest #QualityDigest #quality #regulatory #audits #auditor #compliance #FDAcompliance #AuditPrep #HereForYou

👉🏻 https://lnkd.in/eRP-he_a #QRxPartners #QRxInforms #MLV #compliance #regulatory #FDAcompliance #MedTech #QMSR #quality #HereForYou

Truly. 🤔 😅 🐄 #QRxPartners #memes #HaveALaugh #moo

🖋️ This week's Warning Letter provides several lessons on classic blunders when responding to FDA inspectional observations. Blunder #1️⃣: When responding to observations of contaminants on test equipment and materials, it isn't sufficient to rationalize it as a rare occurrence and not an impact on product quality. What's the basis for and definition of "rare"? And, if testing doesn't impact product quality, then why is it being performed? The latter is simply illogical, while the former lacks a scientific basis. Blunder #2️⃣: When responding to a repeat finding, promising to re-train employees once again is meaningless. It didn't work the first time; why would it work now? The real issue is that blaming employees is never a valid root cause. Not surprisingly, the FDA wanted to know how training effectiveness was assessed and whether any process-related root causes were considered. Blunder #3️⃣: Repeat Blunder #2 on a different process, thereby bringing the Quality Unit's effectiveness into focus. Who's watching over all of these nonconformances? Blunder #4️⃣: Blaming complaints on the product user/patient is just avoiding responsibility and accountability. If the user/patient can cause the product to fail, why isn't the product designed to prevent this? Blunder #5️⃣: Not thoroughly investigating complaints speaks of a lack of attention to detail. When a complaint alleges three separate issues, you can't just investigate one of them. You also can't just randomly cite scientific publications when they don't actually relate to your conclusions. Oh, and using expired products as the basis for the investigation is probably going to raise some red flags. 🚩 🛑 The bottom line is that these blunders are just related to responding to inspectional observations but indicative of not establishing a suitable, adequate, and effective QMS in the first place. Each could have been considered when developing QMS procedures, thus avoiding the inspectional observations, the repeat of those observations, and ultimately, a Warning Letter, not to mention likely follow-on actions like import restrictions. Read the entire FDA Warning Letter here 👉 https://lnkd.in/gJeTdbrK #QRxPartners #QRxInforms #MLV #InadequateResponse #FDA #FDAcompliance #FDAwarningletters #compliance #regulatory #CDER #pharma #HereForYou

🤔 Are you in Medical Devices, Pharmaceuticals, Biologics or In-Vitro Diagnostics and wondering if your Quality System is up to par? We're here to help! This is just one of the many areas of expertise in which the QRx Partners specialize. Find us on YouTube 👉 https://lnkd.in/gMjAKrTY Our Website 👉 www.qrxpartners.com Check our street cred 👉 QRx Partners Steve Gompertz & Mark Swanson Contact us anytime to start a friendly, obligation-free conversation at contact@qrxpartners.com. Let us help you start 2025 in compliance. 🤝 #QRxPartners #QRxInforms #MLV #QRxSpecialties #QualitySystems #audits #MedTech #compliance #FDAcompliance #regulatory #pharma #pharmaceuticals #biologics #diagnostics #FDA #HereForYou

Check out this inspiring UCLA Ventures event coming up next week in San Francisco! QRx Partners Business Development Manager Michel Locquegnies will be in attendance! 👏 Event link 👉 https://lu.ma/oxa4pshx #QRxPartners #QRxInforms #MLV #StartUps #entreprenuer #UCLA #LifeSciences #pharma #pharmaceuticals #healthcare #therapeutics

There's an excellent Regulatory Affairs Professionals Society (RAPS) Twin Cities Chapter event coming up this month! QRx Partner Mark Swanson will be there as a featured mentor. Scroll for more info and event links: ✅ Gain valuable mentorship and career insights. ✅ Build connections with leaders across the Minnesota regulatory community. ✅ Learn best practices and strategies to grow in your regulatory career. Who should attend? ✅ Those aspiring to move into Regulatory Affairs, Regulatory Affairs Specialists, Regulatory Affairs Coordinators, and Regulatory Affairs Managers. This event is a meaningful way to develop professionally, expand your network, and get inspired by experienced leaders. Event on LinkedIn 👉 https://lnkd.in/gHZK-y9P Event website 👉 https://lnkd.in/g_K3KD6P #QRxPartners #QRxInforms #RAPS #MLV #regulatory #mentor #compliance #FDAcompliance #MedTech #HereForYou