Carl Miller MeD

Identify and eliminate recurring errors efficiently with SECA's precise root cause analysis and get suggestive & actionable CAPAs. Simplify your investigative process and ensure consistent improvement with SECA's user-friendly interface, empowering your team to tackle issues head-on and maintain operational excellence. Streamline your error management and enhance your QMS with SECA! #innovation #technology #investigations #linkedin

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The terms cleaning and disinfection are often used interchangeably, but they represent distinct processes, especially in the context of pharmaceutical manufacturing. Understanding the difference between these two processes is crucial for maintaining high standards of hygiene and contamination control in sterile environments, such as those used for injectable drug production.

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Documentation is key in demonstrating compliance in FDA-regulated fields. From URS to PQ and RTM, each type serves a crucial role! E2i's validation services help streamline this process, ensuring your systems meet industry standards and operate smoothly!

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Documentation is key in demonstrating compliance in FDA-regulated fields. From URS to PQ and RTM, each type serves a crucial role! E2i's validation services help streamline this process, ensuring your systems meet industry standards and operate smoothly!

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🔓 Unlock the secrets of #FDA's PMA submission process with our comprehensive guide. From navigating #regulations to streamlining documentation, empower your journey towards FDA approval. 👇 Explore essential tips, best practices, and expert insights to maximize your success. 📈 ⬆ Elevate your understanding and conquer the complexities of PMA submission effortlessly. Read our blog now 👉 https://lnkd.in/gyDMSsDv

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https://lnkd.in/gRmmHkjs FDA does/does not expect you to follow cGMP completely on an investigational drug pertaining to parts 210 and 211 in phase 1? Yes the official gab is that this is to streamline and help drug development. The devil resides in "completely”, what does this mean in government FDA terms? Was this really done to aid good drug development or aid the agency’s inspection burden? These and many more questions swirled around FDA real intentions when it does something like this. So in saying it doesn’t have to meet "all” the cGMPs of approval/commercial, the questions are really pertain to which ones must it meet? The answers, are really not given. Classic FDA moves, we will let you know which ones when we have a problem you caused. As to the boiler plate clarification sessions the agency promotes they are nothing more than clarification of it’s side steps it all ways takes to leave wiggle room for its enforcement policy. Yes of course we define the wiggle. Yes we don’t mean you can just mix the stuff in the vat without "any” cGMPs, just not all. Kinda reminds me of you of your golf posse is telling you, you can have some of the beer. You end up drinking one too many and they quickly yell they didn’t tell you you could that many. Disclaimer, this commentary is not meant to imply all FDA guidance is bad, just the ones I pick.

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READ: FDA Finalizes New Final Guidance on Facility Readiness and Goal Dates https://lnkd.in/e8wBEB9P Author: Bob Pollock #ANDA #FDA #Generics #OGD #RegulatoryAffairs

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Looking to understand the updates to USP <797> Guidelines on sterile compounding?   Watch a recorded presentation by Abby Roth, a microbiologist and consultant on sterile compounding. Her presentation focuses on: ⁃ Patient safety ⁃ Additions to the compounded sterile product (CSP) categories ⁃ Revisions to beyond-use-dates (BUD) ⁃ Contamination control considerations   View the webinar: https://lnkd.in/eDR-ypJz   #baxter #baxterpharmaceuticals #USP797 #compoundedsterileproducts #premixIVmedication

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🚀 Choosing the Right RIMS in 2024: Stay Ahead of Regulatory Changes! 🚀 As regulatory affairs continue to evolve, selecting the right Regulatory Information Management System (RIMS) is critical for staying compliant and efficient. What should you look for in 2024? Think automated compliance tracking, seamless integration, data security, and advanced analytics—all in one platform. From scalability to cost-efficiency, the right RIMS makes all the difference. Freyr SPAR is designed to meet these demands, ensuring compliance, ease of use, and future-proof growth. Ready to optimize your regulatory operations? Click on the link in comment section! 🌟 #RegulatoryAffairs #RIMS #RegulatoryExcellence #Compliance #FreyrDigital

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FDA'S NEW BIOSIMILAR GUIDANCE The FDA's updated guidance eliminates the need for switching studies for biosimilar interchangeability, emphasizing the importance of robust analytical and clinical data. This shift accelerates biosimilar approvals while maintaining safety and efficacy At QxP, we provide unparalleled expertise in interpreting these evolving regulatory requirements, ensuring compliance and expediting your product's journey to market. Learn how our comprehensive consulting services can support your biosimilar development. https://lnkd.in/eUE4erAt #pharma #biotech #qualityassurance #biosimilars

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US FDA 𝐄𝐬𝐭𝐚𝐛𝐥𝐢𝐬𝐡𝐢𝐧𝐠 𝐚 𝐂𝐮𝐥𝐭𝐮𝐫𝐞 𝐨𝐟 𝐐𝐮𝐚𝐥𝐢𝐭𝐲: 𝐄𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 🆀🅼🆂✅✅✅ 𝐀 𝐫𝐨𝐛𝐮𝐬𝐭 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐜𝐮𝐥𝐭𝐮𝐫𝐞 𝐢𝐬↗️ ⏹️Vigilant and Proactive ⏹️Patient-focused ⏹️Science and risk-based ⏹️ Able to identify issues while they are still small ⏹️ Readily meets Good Manufacturing Practice ⏹️ Responsible for assuring any supplier or contract site is qualified to do the function & performed it satisfactorily ⏹️ Supportive of business needs because assuring quality creates higher yield, dependability, and sustainability ⏹️𝘐𝘵 𝘴𝘩𝘰𝘶𝘭𝘥 𝘯𝘰𝘵 𝘣𝘦: ❌Reactive or defensive (issues should be surfaced) ❌Solely a procedural approach (only “plan-do,” without “check-act”) #FDA #USFDA #QMS #Pharmaceuticals #Quality #QualityCulture #GMP #PharmaIndustry

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Regulatory professionals face major challenges in managing compliance, updating labeling, and meeting stringent deadlines. Sponsored content from Schlafender Hase: Based on the results from most recent Global Compensation and Scope of Practice Report published by RAPS, here are the top 5 ways TVT, the document comparison software for regulatory affairs can help you meet these challenges: https://bit.ly/4bmhKgR

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Are you a sponsor that chose the wrong CRO? Does your study need to be "rescued"? If so, we should talk. I am confident that I will be able to help you bring your study back into compliance and get things back on track. #medicaldevice #pharma #clinicaltrials #clinicalresearch

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🌡️🛡️ ELPRO's GxP services team recommends temperature mapping during extreme summer months to avoid product degradation and ensure compliance with GDP and GMP guidelines. Here’s why it’s crucial: 1. Regulatory Compliance: Meet FDA and WHO guidelines with documented proof. 2. Risk Mitigation: Identify hot and cold spots to develop risk-avoidance strategies. 3. Improved Product Quality: Prevent spoilage and maintain high quality. 4. Cost Savings: Use resources and energy more efficiently. 5. Increased Customer Confidence: Provide proof of proper storage and transport. Ensure safety and compliance this summer with temperature mapping. Learn more: https://hubs.li/Q02yncyj0 #TemperatureMapping #Compliance #ProductQuality #RiskManagement #ELPRO

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Are you dreading an upcoming regulatory agency inspection? FDAQRC’s Inspection Readiness Program can help you feel confident and prepared! FDAQRC’s Inspection Readiness services are personalized for each project to ensure they meet quality and regulatory standards. We offer audits, training, GAP analysis, and much more to fit your project’s exact needs. Interested in discussing our Inspection Readiness program? Fill out our form and our team will reach out to you! https://hubs.ly/Q02VjYhz0 #inspectionreadiness #regulatorycompliance #audits #FDA #EMA #regulatoryagency #inspection

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Harris vs. Trump: What the Presidential Election Could Mean for the Biopharma Industry As the 2024 election approaches, the close race between Vice President Kamala Harris and former President Donald Trump is sparking significant discussion about potential impacts on the biopharma sector. Analysts and industry stakeholders are weighing in on key issues like drug pricing reforms and regulatory policies that could shape biopharma's future under either administration. 🔴Potential Impacts Under a Trump Administration 🔴 Some believe a second Trump term could favor biopharma. According to BMO Capital Markets analysts Evan Seigerman and Kostas Biliouris, PhD, the industry might benefit from: 🔴Inflation Reduction Act Stability: The IRA may not expand and could be repealed. 🔴Less FTC Scrutiny: Potential decrease in Federal Trade Commission oversight on biopharma. 🔴Drug Pricing Reforms Targeting PBMs: Reforms may focus on pharmacy benefit managers (PBMs) over manufacturers. However, Trump's stance on drug pricing has been unpredictable. He has supported measures like price controls, not typically aligned with Republican positions, adding uncertainty for the industry. 🔵 Potential Impacts Under a Harris Administration 🔵 Vice President Harris's plan focuses on tackling high drug prices by addressing both PBMs and pharmaceutical companies. Key aspects include: 🔵 Cracking Down on Anti-Competitive Practices: Targeting practices that inflate drug prices. 🔵 Accelerating Medicare Negotiations: Speeding up talks to reduce medication costs faster. 🔵 Potential Use of "March-In Rights": Considering invoking Bayh-Dole Act provisions for reasonable pricing on federally funded drugs. While these measures aim to lower costs, some industry experts express concerns about unintended consequences. Invoking march-in rights could affect pharma-academic partnerships, potentially impacting innovation. The Industry at a Crossroads As election day nears, the biopharma industry is closely monitoring developments. The outcome could significantly influence regulatory policies, drug pricing reforms, and the business environment for pharmaceutical companies. Looking Ahead Regardless of the election outcome, biopharma will continue to face challenges in drug pricing, innovation, and regulation. Stakeholders are encouraged to engage in dialogue to find balanced solutions that promote both public health and industry growth. Join the Conversation What are your thoughts on how the election might impact biopharma? How do you see policies shaping the future of drug pricing and innovation? Share your perspectives below. Here a great article from BioSpace on this topic: https://lnkd.in/dv7dyphx

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https://lnkd.in/gre8mUg8 If one is to look at a common denominator among these five FDA historical cases. We would see time, the time that transpired before the FDA system reacted to the risk. In the FDA business time is risk exposure and by default many times, loss of life. Fast forward to today and cases like the CPAP Phillips device and we see not much has changed in the agency’s timed reaction protecting the consumer to large scale risk. One can play the devils advocate and claim that many other cases were prevented to develop to this national impact. True, but if we are to apply the quality concepts the agency applies on its clients, validation, CAPA, and the rest of GMPs to lessons learned to its own operations what happens? What did the agency learned from all these historical cases that it applied to the Phillips case for example? This week we had one of the largest bottled water recalls in the history of bottled water. If you look at the causes of the recall it is time again. The conditions are time related negligence of company quality control and time related failure of the agency to inspect. Negligence, time after time in reacting to risk, much like most national cases. What are the primary factors that cause this reaction time issues? Maybe we need time to think about it?

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Technology keeps advancing and so should your GXP application testing strategy.  With the move to the SaaS model manual testing following a script is not practical.  Automation will take over reducing time, effort while reducing risk and improving compliance. Let Lean Biologix show you how.

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At GxP Impact Consulting LLC., safety and community are core values in everything we do—including how we celebrate Halloween! One popular tradition we support is "Trunk-or-Treat," a safer and more convenient alternative to traditional trick-or-treating. Here’s why it’s a great option for families: Why Trunk-or-Treat? 1. Safety First: With a controlled, well-lit environment, kids can enjoy Halloween without worrying about busy streets or unsafe conditions. 2. Convenience: Everything happens in one spot, making it easier for parents and allowing children to collect candy more efficiently. 3. Community Spirit: These events bring neighbors, families, and friends together, fostering a sense of connection and shared fun. 4. Inclusivity for All: Perfect for younger children or those with mobility issues, plus many events offer allergy-friendly treats. 5. Extended Fun: It’s more than just candy! Enjoy games, contests, music, and creatively decorated trunks that make the experience interactive and exciting. Whether you're choosing traditional trick-or-treating or opting for Trunk-or-Treat, the most important thing is that everyone stays safe and has fun. Happy Halloween from GxP Impact Consulting! 🎃 #TrunkOrTreat #HalloweenSafety #Community #GxPImpact #SafetyMatters

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