QRx Partners

😀 Let's have fun kicking off this work week after a long weekend! What was something memorable you did or experienced over the past few days? Did you get up to the cabin? Did you spend time with friends or family? Did you finally finish that project you've been putting off at home? Or did you finally have time to put your feet up and enjoy the fireworks? 🇺🇲 Comment and tag below! #QRxPartners #4thofJuly #Celebrate #SummerCelebrations #Community

Celebrate responsibly this weekend ... 😉 🐜 🎆 #4thofJuly #FarSide #funny #tgif #summer

Land of the Free. Home of the Brave. Enjoy your 4th of July - America's Day of Independence. 🇺🇲 #July4th #IndependenceDay #America #Merica #Patriotism #Patriotic

🖋 With the rise in popularity of diabetes medications for weight loss, a dangerous trend is emerging. The high costs and lack of insurance coverage are driving patients to seek low-cost alternatives, which creates an opportunity for unscrupulous companies to profit. ➡ This week's warning letter isn't about what could have been done differently. It's a warning to patients to be wise and understand how regulations protect them. Awareness of these regulations is crucial. ➡ Meeting market demand is essential for drug manufacturers. More manufacturers can improve the supply chain, make important drugs more accessible, and possibly drive down prices through competition. ➡ However, there are no shortcuts. Just because one company produces a drug doesn't mean another can produce or sell the same drug without proper registration. ➡ More importantly, drugs must be sold according to FDA approvals, especially concerning dosage and prescription requirements. 🛑 In this case, the seller isn't requiring a prescription and is offering the drug in dosages significantly higher than approved by the FDA. The maximum FDA-approved dose is 2.4 mg, but this seller is offering 4 and 8 mg! 😳 That's absolutely crazy and dangerous! Key Takeaways for Patients: ✔ Understand and Follow FDA-Approved Dosages: Higher than approved dosages can lead to severe health complications. ✔ Always Use Prescriptions from Medical Professionals: Never bypass the prescription requirement. ✔ Check FDA.gov for Reliable Information: The FDA provides a wealth of information for the general public. ✔ Awareness of the regulations isn't just for quality and regulatory professionals; it's also for patients. This is why FDA.gov contains tons of information for the general public. Make use of this information, and be safe out there! Read the full Warning Letter here 👉 https://lnkd.in/gqd8D3Ug #QRxPartners #QRxInforms #MLV #InadequateResponse #FDA #WarningLetters #FDAcompliance #WeightLoss #CDER #Medications #WeightLossMedications #WeightLossTrends #Regulatory #Compliance

Looking to enter the US market and need help with regulatory compliance? Connect with one of our partners in the UK, who will be there to help answer questions! We will be covering a wide range of topics, including: ✔ Regulatory requirements and processes ✔ Managing FDA relationships to maximize results ✔ Quality system assessment and auditing ✔ QMS development and improvement ✔ Clinical/performance evaluation reports Spaces are limited, so register now to secure your spot. 👉 https://lnkd.in/giFNNMDh Many thanks to Go To Market Global for hosting! #QRxPartners #QRxInforms #MLV #QMS #USmarketentry #FDA #RegulatoryFramework #RegulatoryCompliance #Regulatory #FDAcompliance #AcrossThePond #Audits #Auditing

Join our partner, Steve Gompertz, next week at the Plymouth Campus of St. Cloud State University while he presents a two-day session on "Understanding Medical Device Quality Systems and FDA QMSR Impacts - What They Don't Teach You at Work". Many thanks to Minnesota Section - ASQ for hosting the event! Scroll for more info and the event link ... 👤 Intended Audience: Anyone who works for a medical device-related organization with either no or minimal knowledge/experience or no formal training in quality management system requirements. This includes anyone trying to determine the impacts of the FDA’s new Quality Management System Regulation (QMSR), which focuses on ISO 13485. Topics Covered (more in-depth info online): Day 1️⃣ ✔ History of Quality, Standards, Regulations, and the FDA ✔ Quality System Basic Concepts & Intents ✔ Management Responsibility ✔ Resource Management ✔ Documents & Records Day 2️⃣ ✔ Design Controls ✔ Production & Process Controls ✔ Purchasing & Supplier Management ✔ Control of Nonconforming Product ✔ Customer Feedback ✔ Audits ✔ CAPA Event Link 👉 https://lnkd.in/gVVdRwBR #QRxPartners #QRxInforms #MLV #SCSU #MNASQ #QMSR #ISO13485 #CAPA #FDA #FDAcompliance #compliance #regulatory #quality

Today, we wanted to recognize all of YOU for taking the time to support US! We're always showing you the many things we have going on, but none of this would be possible without all of our wonderful clients, colleagues, team members, supporters, and, of course, our families. Thank you for your continued support over the years. #QRxPartners #gratitude #thankful #tgif

The struggle is real. 🍪🤣

Please note the updated time for tomorrow's presentation with our QRx partner Steve Gompertz and the UCLA Anderson School of Management - 3-4 p.m. central time. Hope you can make it! Event link 👉 https://lu.ma/l8rtvqb0 #QRxPartners #QRxInforms #MLV #UCLA #Webinar #StartUps #MedicalDevice #Regulatory #QMS #Quality #FDA #HereForYou

🖋 It was a slow week for Warning Letters, with only two to choose from. 1️⃣ was yet another hand sanitizer manufacturer that did not understand that these products are considered drugs. As usual, they: ✔ Failed to establish a Quality Unit with any authority ✔ Didn't validate their water systems ✔ Didn't conduct incoming or final testing. We're starting to wonder whether any hand sanitizer manufacturer is in compliance. 🤔 👉 https://lnkd.in/giRSJ3Zs 2️⃣is interesting as it involves a type of entity under the Center for Biologics Evaluation & Research (CBER) we rarely hear about - a tissue bank, specifically an eye bank. Although the requirements for these operations are very different from what we're used to for devices and drugs, the underlying concepts are similar: registration, good practices, reporting, labeling, etc. 👥 In this case, donors could be considered equivalent to suppliers. This means that there are requirements for properly selecting and evaluating eligible donors. The facility's procedure for donor eligibility didn't sufficiently demonstrate a risk-based approach. They failed to identify clear "red flags" that should have invalidated many donors even though the information needed for a clear evaluation was available in every case. 🛑 Their response didn't help, as it demonstrated a lack of basic risk management knowledge. Setting the probability threshold at 100% doesn't address the role of probability of occurrence in risks. Then, there was a half-hearted attempt to appease the FDA by updating the procedure but not addressing the root causes. Essentially, they doubled down on their existing methods by adding more misguided rationale without attempting to refine the methods. 👉 https://lnkd.in/gcDh7ryX It's always hard to say what went wrong just by trying to read between the lines of a Warning Letter and reviewing their personnel on LinkedIn. As experienced auditors, we would likely start by looking at leadership and management responsibility relative to establishing an effective quality culture. Even when internal resources are competent, they can become unintentionally biased or complacent over time. This is another good reason to engage external experts who can help you see what you may have become blind to. As we always recommend, engage consultants before there are problems. Organizations with truly strong quality cultures understand that they must constantly challenge themselves on whether they're as good as they think. QRx Partners is always ready to give you an honest assessment. 🤝 #QRxPartners #QRxInforms #MLV #FDA #WarningLetters #InadequateResponse #CBER #Compliance #Regulatory #FDAcompliance #HereForYou #QualityCulture