Satapa Dhamankar, RAC

Create your own educational journey with the RAPS Regulatory Affairs Certificate Program. Through a series of courses, you can craft a professional development plan that fits your budget and your busy work schedule. Explore topics like medical devices, pharmaceuticals, quality and clinical. As 2024 comes to an end, it's a good time to map out your 2025 professional goals. Learn more about this popular program today: https://hubs.la/Q02_pQtq0

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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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💡 Final version of FDA's Guidance "Advanced Manufacturing Technologies Designation Program" This guidance provides information about the process to request that an innovative pharmaceutical approach or technology that has the potential to improve the reliability and robustness of the manufacturing process and supply chain can be designated as an Advanced Manufacturing Technology (AMT)

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This is part 2 of our series ‘Fundamental risk concepts’. In this first part we will cover : → Risk control options → Risk control decision → Risk control implementation → Risk control completeness +Bonus : Criteria for ‘information for safety’ 🔜 Next week we'll continue this series, looking at risk acceptance, state of the art & more... ✅ To go further, implement our medical device risk management methodologies and templates: https://lnkd.in/eTw2VVXp ❗ PS: No bob was injured writing this series of ‘Fundamental risk concepts’.

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We live and breathe regulatory compliance. Azzur Group's GMP consultants are immersed in the standards set forth by the FDA, EMA, and other regulatory bodies including: ✅ 21 CFR Parts 11 and 820 ✅ FDA 2011 Process Validation Guideline ✅ Eudralex Volume 4 (EU cGMP Guideline) Have questions about your quality and compliance? Get your answers here: https://azzur.co/3xbIL8H #Compliance #GxPConsulting #LifeScience

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In the words of M Hall, "Words are potent weapons for all causes, good or bad." Words have the power to build someone up or bring them down. They can uplift and enlighten, or depress and destroy. Choose how you speak to yourself and others carefully. #PowerOfWords #PositiveCommunication #enlighten #uplift #networking #pharmacovigilance

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Unveiling FDA Trends! Discover the top Equipment Qualification observations of 2024. Sign up now at fdatracker.ai to know more!

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FDA recalls have significantly increased over the last six years and the 🔑 to avoiding one is staying on top of quality management. Learn more about some key components of product recall avoidance in MasterControl's guide here: https://lnkd.in/e_ZhWVxr #drugrecalls #qualitymanagement #lifesciences #FDA

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This is a great read. It highlights the need for successful FDA enegaements, it goes beyond a regulatory matter - it’s cross-functional. This is where I feel internal audits, mock audits, etc. bring tremendous value to an organization. Establishing plans and building capability is key. #RAPS #MedicalDevice #FDA #regulatoryaffairs #qualityaffairs

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(Benefit-Risk Management / Mass Balance Studies / Final FDA Guidance) So if you don't have a clinpharm-friend, here is the short definition of a [human radiolabeled w/^14C,^3H] mass balance study - MBS is the single most direct method to measure ADME of drug in the human body, AND measure circulating metabolites, relative concentration of metabolite : parent drug, prioritize metabolites needing further safety assessment, and assess if renal/hepatic/DDI studies needed. Simple? Read-on. Enjoy. #fda #cder #nonclinical #drug #radiolabeled #massbalance #clinicalstudy #adme #clinpharm #pharmacology #cber #biologics #adc

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🌟 Game-Changer in Drug Manufacturing! 🌟 The FDA’s new final guidance, Advanced Manufacturing Technologies Designation Program, is a big step forward for the pharmaceutical industry. This program allows companies to request an advanced manufacturing technology (AMT) designation, unlocking expedited development and assessment for drugs produced using these cutting-edge methods. 🚀 Innovations like these are paving the way for more efficient, reliable, and scalable drug manufacturing. Curious about the details? Check out the full guidance here: https://lnkd.in/e-i5nzrC #PharmaceuticalInnovation #AdvancedManufacturing #FDA #LifeSciences #DrugDevelopment

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Sharing this insightful blog on regulatory agilities from my colleague Janis Bernat , Director of Scientific & Regulatory Affairs at IFPMA « Regulatory agilities will be critical to address the next pandemic. But, already today, NRAs have the opportunity to continue implementing certain agilities, securing efficiencies in regulatory processes, and promptly addressing patients’ needs. » #regulatoryaffairs #regulatoryscience #IFPMA #WHO #Medicnes #innovation

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FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

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FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

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FDA PCCP Guidance: Stay ahead with the latest ‘FDA PCCP Guidance.’ This document provides critical updates to help you align your practices with regulatory expectations. #FDA #PCCP #RegulatoryCompliance

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Happy New Year, everyone! The FDA is starting the year strong, releasing over 20 guidance documents this week alone! Among them is an important update: "Considerations for In-Process Sampling and Testing of Drug Products." 💡 This guidance provides key insights for ensuring quality and compliance during manufacturing. 📌 Take a look, and don’t hesitate to reach out if you have any questions or need expert support in navigating these requirements. https://lnkd.in/ghKmC_k8

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Is it time to re-evaluate your CAPA processes? If your CAPA management isn't up to par, you could get cited by the FDA. Inefficient CAPAs are one of the most common reasons companies receive Warning Letters. Take a look at these strategies for ensuring you have successful CAPA management. Audit your CAPA process with OQSIE. Contact us for a free quote: www.oqsie.com/contact #capa #lifesciences #qualitymanagement

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