Stephen Levine

Our Regulatory team tracks and shares a selection of new regulatory guidance each month to help you keep up to date. 📖Take a read of the March edition to learn about the FDA final guidance, draft guidance, monthly approvals and much more...👇 https://bit.ly/3QmqeNe #FDA #Regulatory

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👉FDA QMSR CHAT: Vincent F. Cafiso and Mac McKeen, MBA, RAC, FRAPS told me complying w/ final Quality Management System Regulation will likely require consultants and temps rather than additional full-time Regulatory and Quality roles. #FDA #QSR #QMSR #ISO13485 #MedCon #consultants #regulatory #quality #RAPS *free story* 👇👇

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Lisa Sellers, CEO of Vector Laboratories, Inc., discovered a passion for science after her very first chemistry lesson and found the subject came easily to her. What is the most valuable lesson List has learned?​ Be flexible & open-minded about what might come ahead. Doing this will provide you with more options and allow you to navigate challenges with resilience and creativity. That open-mindedness can be quite freeing from stress, fear, and a need for control. By being proactive, curious, and open to new experiences, young women can set a solid foundation for a successful & fulfilling career in the life science industry. She encourages them to leverage the abundant resources available. Information is at our fingertips in the digital age, and platforms like online courses, scientific journals, and educational websites can be immensely helpful in gaining foundational knowledge. Networking is crucial in any career. The earlier one starts, the better. Talk to as many people as possible, attend science-related events, and connect with professionals in the field. Finding a mentor can be transformative. Seek individuals who have paved the way in your field of interest and learn from their experiences. #biotechnology #lifesciences #leadershipdevelopment #InsightSherpa

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Drug Supply Chain entities-update to DSCSA Announced by FDA: transition to electronic systems “Under the DSCSA, trading partners – primarily manufacturers, wholesale distributors, dispensers, and repackagers – are subject to certain requirements for enhanced drug distribution security. The DSCSA, enacted in 2013, outlines steps to achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed throughout the U.S. Currently, these entities can choose to provide such information either electronically or in paper format. These DSCSA requirements are scheduled to change on November 27, 2023, and will include requiring trading partners to provide, receive and maintain documentation about products and ownership only electronically. The stabilization period will accommodate an additional year, until November 27, 2024, to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems.” #drugsupplychain

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💊🧪 In a recent session at #DaywithDISA 2024, Brady Quarles, Vice President of Industrial and Consortium Sales for DISA Global Solutions, provided a comprehensive update on #drugtesting trends, the significance of maintaining robust drug and alcohol programs, and the increasing challenges due to rising illicit drug use. His presentation underscored the necessity for organizations to adapt their drug and #alcoholtesting policies to stay ahead of emerging trends and maintain a safe workplace. Key takeaways include: ☑ Overdose Deaths Skyrocketing ☑ Rise of Fentanyl ☑ Cost to Employers ➡ Did you miss the live presentation, or would you like to revisit it? Rewatch the presentation here: https://lnkd.in/giHdfjVF #BackgroundScreening #MarijuanaLegalization #Compliance

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Discover the latest insights on viable sampling in sterile compounding! Abby Roth, from Pure Microbiology LLC, discusses its challenges and limitations in our newest blog post. Gain valuable knowledge to enhance your sampling program. https://hubs.la/Q02w8lbG0

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Medical device OEMs and contract manufacturers should include this in the external variables impacting your mid-term and strategic plans.

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So looking forwards to learning more about this final rule. Eric Henry is a seasoned, industry veteran in this space, and I would highly, highly recommend listening to his previous webinar on the same topic but on the proposed rule- "QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance". This will help to connect the dots on how it all started and how this final rule was developed. Greenlight Guru

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With the deadline for EUDR drawing closer, the number of tools and solutions that purportedly help with compliance is multiplying. This highlights how complex and challenging the journey to EUDR compliance can be – but every journey starts with a first step, and GFW Pro is a trusted, cost-effective starting point for meeting due diligence requirements. Our latest blog discusses how our tools can support risk assessment 📊 across different commodities and countries, which maps and data sets on our platform are relevant to the EUDR 🗺️, and why publicly available data remains valuable in a rapidly evolving landscape. 🌳 Learn more here ➡️ https://lnkd.in/eyyuFqz3 #gfwpro #deforestation #supplychains #climate #eudr #sustainability #forests

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Why aren’t DMR, DHR and DHF named in FDA's Final Rule on the new Quality Management System Regulation (QMSR)? That's because QMSR is incorporating ISO 13485:2016 by reference, and ISO 13485:2016 doesn’t use these three terms. Instead, it uses the term Medical Device File (MDF) to refer to all the records that are traditionally split up amongst the DMR, DHR, and DHF. In this article, we explain FDA’s decision and elaborate on what this means for medical device manufacturers going forward. Read more here: https://bit.ly/3yWAOEL #qmsr #qualitymanagement #qualitymanagementsystem #fda #medicaldevices #medtech #greenlightguru

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Recent inspections at aseptic manufacturing facilities have uncovered certain trends, including failure to identify the root cause of contamination, investigate media fill failures, conduct proper sterility testing or implement adequate environmental monitoring programs. People in cleanrooms are significant sources of contamination; manufacturers of sterile drugs should implement closed barrier systems to reduce the risk of contamination. Brooke Higgins, FDA/CDER Senior Policy Advisor for the Global Compliance ISPE #2023_ISPE_Aseptic_Conference #compliance #fda #research #manufacturing #environmental #people #media #testing #contamination #sterility

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If you have been following my postings on the lead- and chromium-contaminated cinnamon apple sauce pouches from economic adulteration with lead chromate, the FDA has published it's final report on the topic. It includes details about sampling, testing and the safety concerns, as well as a conversation with Conrad Choiniere, the Deputy Director for Regulatory Affairs at FDA's Center for Food Safety and Applied Nutrition (CFSAN), who answers questions on consumers' minds and explains what else the FDA is doing to enhance the safety of cinnamon and other spices in the U.S. market. However, what struck me is that he doesn't think the elevated levels of lead detected in these products could have been entirely prevented through action levels (maximum limits), although he goes on to say that end-product testing would have been very helpful in preventing these products from entering the market. It makes for fascinating reading and clearly shows there are limitations in a regulatory system where federal law does not explicitly require industry to test food ingredients or final products for contaminants. The report can be found at the following link: https://lnkd.in/ehNSp7T6 Please share with your colleagues. Best, Rob #food safety, #food contamination, #heavymetals, #babyfood,

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As the November 2024 deadline approaches, it's imperative for all pharmaceutical distributors to ensure full compliance with the DSCSA regulations. Transaction Reports (T3) are essential for maintaining the security, traceability, and legitimacy of drug products throughout the supply chain. These reports help verify authenticity, facilitate recalls, and detect counterfeit products, ensuring a safe and compliant distribution process. 🔗 To understand more about the significance of T3 reports and how they can help your business stay compliant, read our blog article: https://hubs.li/Q02Ff4310 #PharmaceuticalDistribution #DSCSA #Compliance #SupplyChainSecurity #PharmaERP #BlueLinkERP

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Join us for our Repligen webinar series that analyzes critical workflows for the technologies that are driving the greatest impact from cell culture to formulation. Bioprocess Workflows that Win Join Senior Vice President Christine Gebski for a four-part webinar series that analyzes critical workflows for the technologies that are driving the greatest impact from cell culture to formulation. Every Thursday in February at 11 AM ET / 8 AM PT February 2nd 11 AM ET / 8 AM PT Disruptive technologies transforming upstream process intensification for all modalities  Melisa Carpio Director, Global Upstream Field Applications February 9th 11 AM ET / 8 AM PT Accelerate your UF/DF process using the only in-line concentration controlled TFF system Derek Carroll Director, Research & Development February 16th 11 AM ET / 8 AM PT Strategic considerations to future-proof single-use assemblies Derek Masser Director, Fluid Management Technologies   February 23rd 11 AM ET / 8 AM PT Innovative, differentiated technologies advancing new modalities: Case studies in mRNA & viral vectors Shelly Parra Sr. Director, Technology Positioning #repligen #bioprocessing #biotherapeutics Contact me for getting you registered! Or register on Repligen.com  

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with so much disruption in prescription drug policy and markets, it is important to understand how biosimlars are developed, priced, covered and recent policy changes in Part D that will impact patients and providers. if you have questions or thoughts, please reach out!

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𝗙𝗗𝗔/𝗖𝗥𝗖𝗚 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽: 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗣𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗮 𝗠𝗼𝗱𝗲𝗹 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲 May 2 - 3, 2024 Over the course of 2 days the FDA and Center for Research on Complex Generics (CRCG) are holding an in-depth workshop aimed at fostering collaboration and enhancing efficiency in #drug product development through the use of 𝗠𝗼𝗱𝗲𝗹 𝗠𝗮𝘀𝘁𝗲𝗿 𝗙𝗶𝗹𝗲𝘀 #MMF. This event brings together model developers & industry experts, to discuss the application and regulatory integration of MMFs in #modelingandsimulation (M&S).   𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀: ✅ Discussion on MMF: Understanding the concept, scope, and #regulatory application. ✅ Model Sharing and Reusability: How MMFs can streamline drug product development and #approval processes. ✅ Interactive Sessions: Engage with #FDA representatives, #drugdevelopers, and #academic leaders ✅ Practical Insights: Learn about the best practices for developing and implementing MMFs in regulatory submissions. InSilicoTrials champions the application of modeling and simulation in #healthcare and is eager to give its contribution toward the implementation of #model integrated evidence (MIE) to increase efficiency in #drugdevelopment while streamlining regulatory approval. ✍ Register here: https://lnkd.in/erCUuMm8

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