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In 2023, 50% of FDA warning letters included all 4 of these categories- poor CAPA Processes, issues with the Complaint Handling for PMS, Insufficient Medical Device Reporting procedures, and problems with the Validation of the Manufacturing Infrastructure with double-digit letters being extended. 7-8 Warning Letters were caused due to Insufficient Supplier controls, Failure to Maintain Record Files, poor Design control processes, and issues with Design Validation & Verification. How important is it for culture to avoid the Cost of Mishires and have fewer wasted resources while increasing compliance to avoid fines and put safe and effective products out in the market for patients? At SSI, in 9+ years our offer acceptance rate has averaged 93%, 54% of candidates have been promoted within 24 months, and they stay 1/3 longer than the industry average for retention. Let's partner on your critical needs positions so we can help you hire for culture! https://lnkd.in/eMCHm28k #FDAWarningLetters #costofmishires #QualityMatters #Medtech #HireforCulture #RiskManagement #TalentManagement
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🚨 𝐂𝐌𝐂 𝐒𝐜𝐢𝐞𝐧𝐭𝐢𝐬𝐭𝐬: 𝐏𝐫𝐞 𝐚𝐧𝐝 𝐏𝐨𝐬𝐭 𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐝🚨 📍 Located in Little Island, Cork, the Global Business Solutions team of over 1,600 optimize and add value to key business operations across the #Lilly company. If you are a Scientist with CMC experience, I want to hear from you. 𝑪𝒍𝒊𝒄𝒌 𝒐𝒏 𝒕𝒉𝒆 𝒍𝒊𝒏𝒌𝒔 𝒃𝒆𝒍𝒐𝒘 𝒕𝒐 𝒕𝒐 𝒂𝒑𝒑𝒍𝒚 𝒕𝒐 𝒕𝒉𝒆 𝒐𝒑𝒆𝒏 𝒓𝒐𝒍𝒆𝒔: 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐚𝐥 𝐒𝐜𝐢𝐞𝐧𝐭𝐢𝐬𝐭 - 𝐂𝐌𝐂 𝐏𝐫𝐞-𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 👉 https://e.lilly/3XFzPD4 𝐏𝐫𝐢𝐧𝐜𝐢𝐩𝐚𝐥 𝐒𝐜𝐢𝐞𝐧𝐭𝐢𝐬𝐭 - 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲, 𝐆𝐑𝐀 𝐂𝐌𝐂 👉 https://e.lilly/4d64NsN #WeAreLilly #CMC #Scientist #preapproval #regulatory #Postapproval
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Pharmacy is science and art https://ow.ly/kbt450TNHuQ Dr Malcolm E. Brown explores how science and art both have a role to play for a pharmacist in communicating and dispensing #Pharmacy
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Developing a new drug is no small feat, and one crucial step in the process is Dose Formulation Analysis. At Inotiv, our team of scientists has extensive experience in efficiently developing methods to analyze various drug formulations. We use cutting-edge technologies and methodologies to ensure your drug formulation is delivered as per protocol specifications. Let Inotiv be your partner in Dose Formulation Analysis. https://hubs.ly/Q02vcFTZ0 #Inotiv #DoseAnalysis #DoseFormulations #DoseFormulationAnalysis #Bioanalytical #ExpectMore
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Facing Drug Charges? Hagar & Phillips Can Help. If you or someone you love is facing drug charges, it’s crucial to have a robust defense to protect your rights and future. At Hagar & Phillips, we understand the stress and uncertainty of these charges. That’s why we’re committed to providing our clients with compassionate, comprehensive legal representation in these difficult times. Our experienced team specializes in navigating the complexities of drug laws, crafting strategic defenses tailored to each client's unique situation. Whether it’s possession, distribution, or manufacturing allegations, Hagar & Phillips is here to ensure your case is handled with the expertise and diligence it deserves. Don’t face this challenge alone; reach out to us for the support and guidance you need. #LebanonTN #DrugChargeDefense #LegalSupport #HagarAndPhillips
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Anyone who has experienced capping or lamination during tablet production knows the frustration that comes from trying to diagnose the issue. In this article, we discuss a possible cause and several solutions. J-hooks are the distinctive wear patterns on punch tips that are a cause of such tablet defects as capping and lamination. If detected early, a J-hook can be easily and quickly repaired, thereby eliminating the need to purchase replacement tools. More information about J-Hook below: https://lnkd.in/dshNqQVX Contact Us and find out more: 📩 info@natolipoland.pl #natoli #natoliengineering #natolitrainings #pharmatrainings #natolieurope #pharma #tooling #punches #pharmacy #web #spareparts #precision #lab #punchesanddies #tabletpress #encapsulationparts #tabletcompression #engineering
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Congratulations to Knobbe Martens partner Adam Powell for being named to Daily Journal Corporation’s 2024 “Top 40 Under 40” list. Mr. Powell, co-chair of the firm’s antitrust practice group, was recognized for his successful track record of resolving technologically complex issues for clients in the medical device, software, electronics, chemistry, and biotechnology industries. In his Daily Journal profile, he shared key lessons and a deeper look into his litigation strategy. Read the complete “Top 40 Under 40” profile here: https://lnkd.in/gGSpuRzc #KnobbeMartens #IPLaw #IPLitigation #40Under40
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End your week with DrugPatentWatch's week in review. Our curated content ensures you are well-informed about the latest trends and patent activities. Gain a competitive advantage with our thorough and timely reports. #DrugPatentWatch #WeeklyReview #PatentActivities #IndustryTrends #CompetitiveAdvantage
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As a lab professional, you focus on developing protocols and running assays. But what happens when you’re suddenly tasked with managing the lab’s equipment? Many lab professionals find themselves in this position, which can be a real headache. From procuring new equipment to ensuring its proper maintenance, asset management can be a time-consuming and frustrating process. Sound familiar? Swipe right to see the top 5 #assetmanagement headaches for #pharma labs and the effective solutions to cure them. Written by: Kayla Miller, Asset Management Group Lead https://lnkd.in/dkVjUrY6
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BD is adding 215 full-time jobs in Connecticut and Nebraska as it boosts U.S. domestic production of syringes, needles and IV catheters. After seeing too many stories of #medtech #meddevice company #layoffs recently, this is welcome news. Associate Editor Sean Whooley has the details on Medical Tubing + Extrusion and MassDevice. (I'll include the MT+E link in the comments below.) #drugdelivery #oncology
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