Vaishali Raghuwanshi’s Post

Advanced Manufacturing Guidance Needs Detail on Benefits, Comments Say: The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) program is a great start for encouraging industry to develop these systems but it needs a lot more detail before businesses will wholeheartedly embrace it, according to stakeholder comments. #fda #financial #lifesciences

Quality is not an act, it is a habit." - Aristotle We are no strangers to the importance of quality. We understand that one small mistake can have disastrous consequences, not only for our company but also for the health and well-being of our consumers. But what about the cost of quality? Are we doing enough to prevent it? Here are the things to think about:  ✅ Prevention  ✅Continuous Improvement  ✅Optimizations  ✅Technology  ✅Monitoring and Improvement #CostOfQuality #PharmaIndustry #Biotech #Manufacturing #QualityAssurance #BioCleaning #Business 👋Hi I'm Luis! 👋    I help Pharmaceutical and Biotech companies by working closely with the client to develop and document a Contamination Control Strategy (CCS), Cleaning Validation Framework and Strategies by using a framework that is process-driven and practical. This helps clients take control of their Cleaning Validation and Facility Cleaning.     ✔️ Join our monthly live online presentation for free, leave me a message to save your seat  

Join us at the Cleaning Process & Validation Conference for a deep dive into the most crucial topics in pharmaceutical cleaning processes. 🔥 This impressive lineup of speakers and topics ensures a comprehensive understanding of the latest advancements and strategies in cleaning validation. Don't miss the opportunity to enhance your expertise and network with industry leaders. 📅 November 7-8, 2024 📍 Munich, Germany & Online 📑 Request full agenda: https://lnkd.in/da4z3R6h Day 2 Topics: ✔ASTM E55.11 Clean by Design: Richard Hall Hall from Rattiinox S.r.l. will introduce holistic strategies to enhance cleanability and operational efficiency. ✔Contamination Control Strategy: Dr. David Vincent, from VTI Life Sciences will provide an overview of contamination control plans and hygiene in cleanrooms. ✔Annex 1 and COP Machines: Fabio Buscaglia from IWT Pharma will discuss the latest on regulatory updates and where we are at Clean Out of Place machines. ✔Permitted Daily Exposures (PDEs): Dr. Martin Kohan, from Trinity Consultants - SafeBridge Europe, Limited will delve into calculating PDEs and their role in cleaning validation. ✔Flexible Single-Use Containment Systems: David Val from ILC Dover will explore the benefits of disposable containment solutions in meeting regulatory standards. Speak Pharma #SpeakCleaning #CleaningValidation #PharmaHygiene #IndustrionHygiene #CIPAdvantages #RiskAssessment #ManufacturingQuality #ValidationStrategies #PracticalApplications #CollaborativeLearning #QA #Digitalization #CleanByDesign #CIP #COP #Annex

Precision is non-negotiable when it comes to air classification in clean rooms for pharmaceutical and life sciences applications. Understanding particle counts and their implications is where we excel, offering you peace of mind in a strictly regulated environment. Entrust your clean room requirements to us, and experience the difference of working with a trusted partner dedicated to your success. Connect with us today to explore how we can enhance your operational efficiency and compliance. #ParticleCounts #CleanRooms #RegulatedEnvironment

🌟 𝗝𝗼𝗶𝗻 𝗥𝗲𝗲𝘀 𝗦𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗮𝘁 𝗜𝗦𝗣𝗘 𝗔𝗻𝗻𝘂𝗮𝗹 𝗠𝗲𝗲𝘁𝗶𝗻𝗴 & 𝗘𝘅𝗽𝗼! 🌟 We're excited to showcase our 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 and 𝗖𝗼𝗺𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝗶𝗻𝗴, 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻, 𝗮𝗻𝗱 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 (𝗖𝗤𝗩) Services at 𝗕𝗼𝗼𝘁𝗵 𝟰𝟭𝟯. If you’re looking to enhance compliance, reduce risk, and improve operational efficiency, our team is here to help! Learn how our comprehensive monitoring systems and CQV expertise can support your critical environments — from pharmaceuticals and biotechnology to healthcare and laboratories. ✅ 𝗘𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 ✅ 𝗖𝗮𝗹𝗶𝗯𝗿𝗮𝘁𝗶𝗼𝗻 & 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀 ✅ 𝗖𝗼𝗺𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝗶𝗻𝗴 & 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 ✅ 𝗧𝗮𝗶𝗹𝗼𝗿𝗲𝗱 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 Let's discuss how we can help you maintain the highest standards in compliance and safety. 📍 Booth 413 Chad Kucharski Greg Jakusik Thomas O'Donnell Dawn Fasenmyer Michael Mothersbaugh #ISPE2024 #ReesScientific #EnvironmentalMonitoring #CQV #Compliance #Pharma #Biotech #Healthcare #Calibration #Validation #LifeSciences

Next week, the PDA New England Fall Chapter Dinner will focus on FDA Inspections: Recent Trends and How to Prepare! Don’t miss this opportunity! #KnowledgeIsPower #PDA #PDANewEngland #NetworkingBoston #Biotechnology #BiotechIndustry #PharmaIndustry #BiotechStudents #PharmaStudents #Networking

𝗠𝗲𝗲𝘁 𝘂𝘀 𝗮𝘁 ISPE 𝗔𝗻𝗻𝘂𝗮𝗹 𝗠𝗲𝗲𝘁𝗶𝗻𝗴 & 𝗘𝘅𝗽𝗼 𝗶𝗻 𝗢𝗿𝗹𝗮𝗻𝗱𝗼 𝗮𝘁 𝗯𝗼𝗼𝘁𝗵 𝗼𝗳 M4 Knick! No more batch loss and accurate measurements at all times thanks to automatic cleaning, calibration and conservation of pH sensors with Knick's unique #cCare system. #Automation throughout the upstream, downstream, and auxiliary processes helps to reduce the risks of human errors, improves operational efficiency, and thus increases the safety and quality of the final product which benefits every patient. For more information, do not hesitate to contact directly Knut Georgy and Ralf Beckmann #theartofmeasuring  #pharma  #pharmaproduction #biopharma #biotechproduction #pharmaindustry #pharmainnovation

Dive into the heart of innovation at #DIAEurope2024! Explore eleven tracks that span the entire drug development lifecycle, including the CMC & Product Quality Track. Led by the experts Sofia Ribeiro (Bayer) and Matthew Popkin (GSK), this track explores the most recent developments in science, technology, and regulations impacting CMC and GMP related activities. Ready to be inspired? Watch the video below as Sofia shares insights into the current CMC landscape and why DIA Europe serves as the ultimate platform for fostering crucial discussions in this field. Hurry, there’s still time to secure your spot! Learn more here: https://bit.ly/3qDyjTV. #Conference #LifeSciences #CMC #RegulatoryAffairs

🔬 Ensuring Product Safety with Advanced Container Closure Integrity Testing (CCIT) In the pharmaceutical and biotech industries, product integrity isn't just a priority—it’s non-negotiable. That’s where advanced CCIT technologies step in, safeguarding products from contamination, degradation, and compliance risks. ⚙️ What We Bring to the Table: ✅ Non-destructive testing methods for efficient quality control ✅ High-sensitivity techniques (vacuum decay, pressure testing, etc.) ✅ Automated solutions for increased precision and throughput ✅ Regulatory compliance aligned with FDA, EMA, and USP standards With innovations like AI-powered analytics, IoT-enabled monitoring, and automated testing, we are redefining how companies achieve seamless product integrity and compliance. Because when it comes to product safety, integrity matters—and so do the technologies we trust. PTI - Packaging Technologies & Inspection LIGHTHOUSE Instruments #CCIT #ContainerClosureIntegrity #PharmaTech #AdvancedTechnologies #QualityControl #ProductIntegrity #PharmaceuticalInnovation

Looking to harness iPSC technology at scale? Let's have a discussion! Since the original methodology was developed in 2006 by Yamanaka et al., the use of iPSCs has grown around the world. But while the basic reprogramming and differentiation processes are well-characterized, it's a far more challenging endeavor to produce large batches of consistent, functional endpoint cells at the scales needed for drug discovery compound screens and disease models. That's why we're applying over a decade of expertise to assist biopharma organizations with their large-scale iPSC needs. Key highlights include: • Quality iPSC manufacturing capabilities from our ISO 9001-accredited production facility • Rigorous QC (and the current development of "functional QC" as standard) to enhance confidence in the cells • Extensive experience with the creation and banking of iPSCs for excellent batch-to-batch consistency in large scale projects To learn more, download our new B2B Directory: https://hubs.la/Q02PtWFf0 If you're looking to scale up your iPSC projects and need a consistent supply of functional cells, get in contact with us at operations@axolbio.com #iPSCs #StemCells #biopharma