Rina Newton’s Post

Wolters Kluwer Health is going to be at NHIA 2024! Have you implemented the new USP <795> and <797> regulations? If you’re not sure, stop by to chat with us at Booth #333. We’d love to discuss all the ways we can help you prepare for your next inspection! In the meantime, learn more here! https://lnkd.in/eumftvZh? #Simplifi797 #pharmacy #compliance

Wolters Kluwer Health is going to be at NHIA 2024! Have you implemented the new USP <795> and <797> regulations? If you’re not sure, stop by to chat with us at Booth #333. We’d love to discuss all the ways we can help you prepare for your next inspection! In the meantime, learn more here! https://ow.ly/QHN750QVVFF #Simplifi797 #pharmacy #compliance

Device experts offer tips on handling warning letter, 483 responses Insights on Handling Warning Letters: Experts in medical device regulation offer valuable tips for effectively handling FDA warning letters. These letters serve as official notifications of violations found during inspections and require prompt attention and corrective action. Thorough Understanding of Violations: It's crucial for companies to thoroughly understand the violations outlined in the warning letter. Experts emphasize the importance of addressing each violation comprehensively and ensuring compliance with applicable regulations. Timely Response: Prompt and thorough responses to warning letters are essential. Experts advise companies to acknowledge receipt of the letter promptly and work swiftly to develop and implement corrective actions to address the identified issues. Communication with FDA: Maintaining open communication with the FDA is key throughout the process. Companies should keep the agency informed of their corrective actions, timelines for implementation, and any challenges encountered. Long-Term Compliance Strategies: Beyond immediate corrective actions, companies should focus on developing robust compliance strategies to prevent future violations. This includes ongoing training, internal audits, and a culture of quality and compliance throughout the organization. https://lnkd.in/gXmcjtDq #FDA #MedicalDevices #RegulatoryCompliance #WarningLetters #QualityAssurance #MedicalDeviceRegulation #FDAInspection #ComplianceTips #HealthcareRegulation #QualityManagement #RegulatoryAffairs #FDAGuidance #MedicalDeviceIndustry #RegulatoryUpdates #RiskManagement

The U.S. DOT might implement new regulations on drug and alcohol testing. The change will allow agencies administering DOT-regulated testing programs to use electronic signatures, forms, and recordkeeping. Currently, the agencies are required to use, sign, and store paper documents only. The U.S. DOT requested public comments from DOT-regulated employers and their service agents regarding the use of electronic signatures, records transmission, and records storage in their non-DOT testing programs. They received 72 comments from industry stakeholders, most of them positive in regard to the implementation of electronic signatures and recordkeeping. DOT will accept further comments on the following link: https://lnkd.in/dSHpB9rq What's your opinion on the implementation of electronic handling of such documents?

Is your business in need of a drug license? Look no further! At PSR Compliance, we specialize in helping you navigate the difficulties of drug license registration in Delhi, ensuring a smooth and hassle-free process. Why Choose PSR Compliance? Expert Guidance: Our team of experts stays up-to-date with the latest regulations and requirements, providing you with accurate and reliable advice. End-to-End Support: From document preparation to final approval, we handle every step of the registration process. Timely Service: We understand the importance of time in business. Our efficient process ensures your license is obtained promptly. Compliance Assurance: We ensure that all your applications and documents meet the necessary compliance standards, reducing the risk of delays or rejections. Don't Let Paperwork Hold You Back! Whether you're starting a new business or need to renew your existing license, PSR Compliance is here to help you achieve your goals. Let us take care of the formalities so you can focus on what you do best - running your business! Feel Free to Visit and Call with the below detail: Call us at +91 7065883416 Visit: https://bit.ly/4dKW4gx #PSRCompliance #DrugLicenseDelhi #BusinessSolutions #RegulatoryCompliance #HassleFreeRegistration #DelhiBusiness #PharmaBusiness #DrugLicense #pharmaceuticalindustry #cosmetics #CDSCO #Medicine

“One of the things that we tell our divisions, and our subsidiaries, is that they have to be thorough,” she said. “You have to provide plans because we also agree there are some things you cannot fix in 15 days. You have to come in with a plan, be thorough and make sure you're understanding your root causes and that you're addressing the root causes.” A very common sense advice from FDA to all manufacturers on how to handle warning letters. The companies have to understand what the issues are and have a plan how to address them and be realistic. I find it a real big challenge for many businesses in being realistic about their timelines. #warningletters #medicaldevices #FDA

ICYMI: In our latest webinar, we sat down with Bill Current, President & Founder of Current Consulting Group, LLC, to explore the takeaways from the 2024 Employer Drug Testing Survey. Watch the full webinar recap to unveil the most up-to-date employer benchmarks and stay ahead of changing drug screening laws and regulations: https://hubs.ly/Q02Ynhxt0 #FAWebinar #DrugTesting

🚀 US Regulatory News: Update from the US FDA 💡 The #FDA has just released its final #guidance on "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products." 📊This crucial document, part of the Real-World Evidence (#RWE) program, outlines key considerations for using #EHRs and medical #claims data in clinical studies. 👉 Check out the full guidance here: RegTrac provides regulatory partner & support services for #medicaldevices and #invitrodiagnostics. Get in touch with us to schedule a 30-minute free consultation with our experts at [email protected] | www.reg-trac.com #RealWorldData #EHR #RegulatoryAffairs #ClinicalTrials #HealthcareInnovation

With this newly released OUS warning letter from last week, dated 15 AUG 2024, we can truly say 'The time has come.' When the 483 for this site was posted abut here in FEB of this year, the lead comment was ' they have time on their side.' [ https://lnkd.in/eSZ9Y_tM ] It seems however that they did not use it well. As you can see in the image below, there were a number of points lacking in their response. (From my reading, I would infer the suggestion made was that a removal of certain staff would have been 'desirable.' That is just my read, of course.) The second violation points out issue with the cleaning and sterilization of equipment. The third is around microbial contamination. The fourth was around investigation. here's a sliver: "You failed to conduct adequate investigations and to implement effective corrective actions and preventive actions (CAPA) to prevent recurrence of vial breakage during manufacturing of sterile injectable drug products. " Let me suggest at this point you should really read the 6 page letter as a pdf for yourselves. A full page relates to Data Integrity. (Most of that seems familiar enough - it was covered this way about 5 weeks ago: https://lnkd.in/etsiAFgy ) I'm trying to say it's a brief enough read, compared to the 20+ page 483. Feel free to follow the link in the first paragraph above to refresh your memory on that, then decide how the process went forward. See what you discover, then apply or omment - or just shake your head? URL: https://lnkd.in/e9ZgNN6z #fda #dataintegrity #sterileprocessing #India

🧐Understanding the reasons for drug & alcohol testing is crucial for maintaining a safe workplace and ensuring regulatory compliance. Whether it's for pre-employment screening, random testing, post-accident investigations, reasonable suspicion/cause, return-to-duty assessments, or follow-up checks, New Era Drug Testing provides comprehensive solutions tailored to your needs. 👌Trust us to safeguard your workforce and uphold industry standards. #neweradrugtesting #alcoholtesting #dotregulation #drugtesting #regulatorycompliance