QRx Partners

“Get closer than ever to your customers. So close, in fact, that you tell them what they need well before they realize it themselves.” — Steve Jobs https://lnkd.in/gDjauUaM #QRxPartners #QRxInforms #values #HereForYou

Check your pantries, people. 🥔 😜 #ThursdayVibes #EatYourVeggies

🖊 There were lots to choose from in this week's FDA Warning Letters, but we did notice a trend in some that we've also observed while performing audits for our clients: over-reliance on Supplier Certificates of Analysis (COAs). This Warning Letter is an example 👉 https://lnkd.in/euyTXjB9 🖊 In theory, there's nothing wrong with asking a Supplier to perform testing and analysis at their facilities and then providing a summary of the results against your requirements. Ostensibly, you would do this when you don't have adequate resources to perform the required testing yourself. 🛑 However, blindly accepting COAs without confirming that the supplier has adequate resources isn't acceptable.  ✔ First, the Supplier's methods and equipment should be assessed to confirm that they can produce valid analyses.  ✔ Second, this assessment must be repeated periodically to ensure ongoing validity.  ✔ Lastly, simply confirming that a COA was provided with each delivery isn't sufficient; you need to review each one to confirm that the results are acceptable. 🖊 It might seem logical to conclude that the Supplier wouldn't have shipped if the results were nonconforming. Still, we see it all the time where there is nothing in the Quality Agreement with the Supplier requiring them to hold nonconforming shipments. Instead, the assumption is that your company will review the COAs and make an acceptance decision and disposition. ✔ And then there's best practice in reviewing and recording COA content for trending and other analyses. That, of course, assumes that the COA includes the actual data. 😳 You'd be surprised how often we see COAs that only state, "All required testing passed." Seriously?! 🤔 How many times do we see recalls due to Supplier issues? Setting up adequate Supplier controls is not only the right thing to do, but it could very well determine whether you stay in business❗ Need to strengthen your Supplier controls? Contact QRx Partners today for guidance 🤝 DM QRx Partners Steve Gompertz or Mark Swanson or email contact@qrxpartners.com 📧 #QRxPartners #QRxInforms #MLV #FDA #FDAwarningLetters #InadequateResponse #COA #CGMP #CFR #Pharmaceutical #Pharma #CAPA #compliance #FDAcompliance #regulatory #HereForYou

We are here to inform you of an FDA update based on this recent FDA Law Blog by Hyman, Phelps & McNamara, P.C. on Draft Guidance on Diversity Action Plans. Click on the link below to read. 👉 https://lnkd.in/g5--StpZ #QRxPartners #QRxInforms #MLV #FDA #FDAcompliance #quality #regulatory #FDAblog #FDORA #DAPs #PMA #CDER #CBER #DrugDevelopment #MedicalDevices #PrescriptionDrugs #Biologics #HereForYou

Event Reminder: Our team looks forward to attending tomorrow's Medical Alley Alley Chats event hosted by U.S. Bank and IQVIA MedTech at the always impressive Allianz Field, home of the Minnesota United FC! Steve Gompertz, Christina Pecoraro, and Michel Locquegnies will be there! Event registration link here 👉 https://lnkd.in/g7vRMhAM #QRxPartners #QRxInforms #MedicalAlley #MedTech #Networking #StPaul #MN #mnufc #allianzfield #iqvia #compliance #quality #mlv

At QRx Partners, we like to surround ourselves with quality (pun intended 😉) partners, consultants, and colleagues. From Accounting and Marketing to experienced Consultants and others, we've got a great "team" of experts. Check them out ... 🤝 Partners: ✔ 3Rivers Tax Service Matthew Engelmann ✔ Embossed Marketing ✔ ETHOS Ltd ✔ Go To Market Global ✔ Kablooe Design ✔ Medical Alley 🤝 Consultants: ✔ Natasha Overbo ✔ Mark J. Swanson - MJS Consulting LLC ✔ Nancy Teasdale and an ever-growing team ... Partners 👉 https://lnkd.in/gkvGPwrC Consultants 👉 https://lnkd.in/g3YZQqFH #QRxPartners #QRxInforms #consultants #partnerships #quality #compliance #regulatory #team #teamwork #freelance #HereForYou

Join our QRx Partner, Steve Gompertz, and Naveen Agarwal, Ph.D., tomorrow morning for a 30-minute podcast on applying a risk-based approach to quality management! Check out the event on LinkedIn here 👉🏻https://lnkd.in/eH9-9G2m #QRxPartners #QRxInforms #MLV #QMS #compliance #regulatory #podcast #HereForYou

The resemblance IS a little uncanny 🤣 #ThursdayVibes #splat #HaveaLaugh

🖋 It really does pain us to see companies get Warning Letters not just because of the original violations observed in an FDA inspection, but also because they didn't understand how to properly respond to those observations. We wish we could get the word out broadly that there are experts ready to help these companies before they get into a worse situation. 🖋 Once a Form 483 or other feedback is received from the FDA, companies need to swallow their pride and realize that their current resources were inadequate to prevent the observations and are, therefore, unlikely to be adequate for responding. 🖋 We also recognize that for smaller entities, there is likely cost pressure as consultants are perceived as expensive. However, that will likely become a case of being "penny wise and pound foolish." Providing a weak response will only serve to escalate the situation, cause the FDA to get more prescriptive in its expectations, and greatly increase the scope of work (and associated costs) needed to remediate the violations; not to mention the potential for lost revenue, warranty/recall costs, lawsuits, reduced market share, and so on. 😳 What may have originally cost $50K—$150K to remediate can balloon to hundreds of thousands or even millions of dollars. 👉 This week's Warning Letter was issued to a company that appears to have made these judgment errors and now finds itself on a dark downward spiral. They were initially observed to have: ✔ Not properly implemented aseptic processes for producing sterile drug products ✔ Not actively ensure data integrity ✔ Not providing the quality unit with authority The inspectional observations were bad enough, but then they compounded the situation by: ✔ Responding with vague promises ✔ Failure to address fundamental flaws ✔ No indication of retrospective investigation ✔ No provision of supporting documentation ✔ No corrective action plan to demonstrate commitment Please, please, please let QRx Partners help you if you find yourself needing to respond to a Form 483. 🤝 Of course, no one can promise that the FDA won't still issue a Warning Letter. Still, there is a difference between receiving one where the FDA points out the inadequacy of your responses and increases the scope of its expectations, versus one where the seriousness of the initial findings warrants a Warning Letter. Still, it acknowledges that your responses have been accepted. Contact QRx Partners today for help avoiding Form 483s in the first place, responding to having already received a Form 483, or responding to a Warning Letter. 🤝 Full FDA Warning Letter here 👉 https://lnkd.in/g7C_ZswU #QRxPartners #QRxInforms #MLV #FDA #InadequateResponse #FDAWarningLetters #form483 #compliance #FDAcompliance #regulatory #HereForYou

We're excited to attend next week's Medical Alley Alley Chats event hosted by U.S. Bank and IQVIA MedTech at the always impressive Allianz Field, home of the Minnesota United FC! Steve Gompertz, Christina Pecoraro, and Michel Locquegnies will be there, and look forward to meeting you! Event registration link here 👉 https://lnkd.in/g7vRMhAM.. #QRxPartners #QRxInforms #MedicalAlley #MedTech #Networking #StPaul #MN #mnufc #allianzfield #iqvia