Riesgos de Calidad: Quality Risk Management | César Roberto Silva posted on the topic | LinkedIn (2024)

Have you woven risk management into your life science product lifecycle? Kurt In Albon, MSc, seasoned pharma quality expert, joined us at Beyond Compliance to explain why you should. Catch the full recording on our YouTube channel! 📽 https://lnkd.in/e3pVVEES#pharma #ichq9 #riskmanagement

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Are your supply chain weaknesses putting patients at risk of not receiving safe, reliable medicines? Contract Pharma article “FDA Watch: Is your Supply Chain at Risk?” outlines the various factors & provides links to a sampling of published documents for public comment: https://lnkd.in/enZJhi5m

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As the high-risk landscape continues to evolve, Payzli remains at the forefront, equipped to address the unique payment needs of emerging high-risk industries. One such sector gaining prominence is the 𝐨𝐧𝐥𝐢𝐧𝐞 𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐬𝐞𝐜𝐭𝐨𝐫. Online pharmacies present a distinctive set of challenges compared to their brick-and-mortar counterparts. With stringent regulations governing prescription medications, age verification, and accreditation, navigating this space requires specialized expertise and robust risk management solutions.At Payzli, we have the knowledge and expertise to provide tailored solutions to such challenging sectors while making sure we align with compliance and regulatory requirements. Our technology-driven approach enables us to verify accreditation through esteemed bodies like the National Association of Boards of Pharmacy (NABP) while ensuring compliance with prescription protocols.By leveraging decades of experience in risk management, we empower online pharmacies to operate confidently in a high-demand, high-volume sector that often faces neglect from traditional processors. In essence, our commitment to innovation and risk management allows us to serve as a trusted partner for emerging high-risk sectors. At Payzli, we're dedicated to facilitating secure transactions and fostering growth opportunities in evolving high-risk industries.#highrisk #onlinepharmacies #pharmaceuticals #risk #merchants

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ICH Q9(R1)FDA GUIDANCE ON RISK MANAGEMENT!!!Quality Risk Management Guidance for Industry.May 2023The revision is intended to provide guidance on #qualityriskmanagement principles and tools that can be applied to different aspects of pharmaceutical quality. The guidance replaces the draft #guidance “Q9(R1) Quality Risk Management” issued on June 15, 2022.New guidance Increased focus on the importance of risk communication and collaboration.potential applications for Quality Risk Management, it was added and developed the applicability to:*Documentation*Regulatory Operation Inspection and assessment*Production validation*Laboratory Control and Stability Studies with OOS Results*Supply Chain controlRisk identification term replaced as Hazard identification.Overall, the amendments in ICH Q9 (R1) aim to provide more comprehensive guidance on the application of quality risk management in the pharmaceutical industry.To learn more connect Pharmexpert Consultant LLP : Info@Pharmexpert.in #training #fda #ich #qrm #pharmaceuticalindustry #collaboration #quality #riskmanagement #supplychain #communication #pharmaceutical #gmp

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Comprehensive Containment Strategies and Cross-Contamination Risk Management in High Potency Active Pharmaceutical Ingredient (HPAPI) Facilities Article delves into the intricacies of #containment strategies and cross-contamination risk management within the realm of high potency active pharmaceutical ingredient (#HPAPI) manufacturing. Emphasizing the significance of personnel protection, #patientsafety , and #productquality, the manuscript navigates through various aspects of containment breach consequences, evaluation methodologies, and the broader context of cross-contamination risk management.#cleaningvalidation #crosscontamination #OEL #pde #ade #pharmaceuticalmanufacturing #validation #comments are always welcome to correct and improve the further knowledge sharing.Disclaimer: The views, thoughts, and opinions expressed in the text belong solely to the author, and not necessarily to the author's employer, organization, committee or other group or individual.

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Hello connection,The revised Schedule M is updated on 6 Jan 2024.It includes the introduction of a pharma quality system (PQS), quality risk management (QRM), product quality review (PQR), and specific guidelines for the qualification and validation of equipment. It also mandates a computerised storage system for all drug products.#pharmacy #gmp #regulatorycompliance

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In the world of pharmaceuticals, ensuring product quality and patient safety is paramount. 💊🏥 Pharmaceutical risk management is more than a practice; it's a regulatory expectation. Regulatory authorities like FDA and EMA demand robust risk management systems for quality assurance.Pharma manufacturers face a complex risk landscape – internal (human errors, outdated tech) and external (regulatory shifts, market changes) risks. Managing these risks is key to success and resilience.🔍 Watch our video below as we dive into a real-world case study highlighting risk management in action. Discover how we navigate internal and external risks to safeguard product quality.Curious for More? 💪 Join us for an exclusive Pharma Webinar with the remarkable Simone Ammons from QuneUp on September 19, 2023, at 4:00 PM - 5:30 PM CET Berlin. 🕓Learn how to navigate those pesky external risks like supply chain disruptions and internal challenges such as contamination and equipment breakdown. 💡In this thrilling webinar, you'll:🔹 Discover how to dance with risk and make informed decisions like a pro! 💃🔹 Master the art of de-risking your processes for smooth sailing! ⛵🔹 Get exclusive tips to future-proof your operations against unexpected curveballs! 🚀Our webinar partner this time is QuneUp™, the superhero of data-driven software tools that slashes equipment downtime and boosts productivity. 🤖⚡️🔗 Register now: https://rfr.bz/l6idttpLet's show risk who's boss in the pharma world! See you there, superheroes! 💥💊#GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing https://rfr.bz/l6idttp

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In the world of pharmaceuticals, ensuring product quality and patient safety is paramount. 💊🏥 Pharmaceutical risk management is more than a practice; it's a regulatory expectation. Regulatory authorities like FDA and EMA demand robust risk management systems for quality assurance.Pharma manufacturers face a complex risk landscape – internal (human errors, outdated tech) and external (regulatory shifts, market changes) risks. Managing these risks is key to success and resilience.🔍 Watch our video below as we dive into a real-world case study highlighting risk management in action. Discover how we navigate internal and external risks to safeguard product quality.Curious for More? 💪 Join us for an exclusive Pharma Webinar with the remarkable Simone Ammons from QuneUp on September 19, 2023, at 4:00 PM - 5:30 PM CET Berlin. 🕓Learn how to navigate those pesky external risks like supply chain disruptions and internal challenges such as contamination and equipment breakdown. 💡In this thrilling webinar, you'll:🔹 Discover how to dance with risk and make informed decisions like a pro! 💃🔹 Master the art of de-risking your processes for smooth sailing! ⛵🔹 Get exclusive tips to future-proof your operations against unexpected curveballs! 🚀Our webinar partner this time is QuneUp™, the superhero of data-driven software tools that slashes equipment downtime and boosts productivity. 🤖⚡️🔗 𝗖𝗹𝗶𝗰𝗸 𝘁𝗵𝗲 𝗹𝗶𝗻𝗸 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗺𝗺𝗲𝗻𝘁𝘀 𝘁𝗼 𝗿𝗲𝗴𝗶𝘀𝘁𝗲𝗿!Let's show risk who's boss in the pharma world! See you there, superheroes! 💥💊#GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

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📚🔬 The GMP-Manual V2.1 provides insights into #RiskManagement in the pharmaceutical industry. It emphasizes the importance of proactive decision-making and process optimization. 💡✅🔒🌍 Balancing compliance requirements and resource limitations is crucial for pharma companies. 📉💰 But by implementing quality risk management principles, they can enhance product quality and reputation while meeting regulatory standards. 🏭🏆💪 The advantages of risk management include transparency, communication, trust-building, and integration into quality management systems. 🤝✉️ It promotes proactive prevention and systematic assessment of hazards and risks. 🎯🚧🌱🔁 Adopting a risk-based approach supported by regulators encourages science-based innovation and faster implementation of new technologies. ⚙️🚀 It's a win-win for patients and companies in the long run. 🏥💊🤝🌐 Effective cooperation between companies and regulatory authorities is key, especially in areas like corrective and preventive actions (CAPA) and change control. 🔄🔧 Optimized processes lead to better outcomes and continuous improvement. 📈🔁#PharmaceuticalIndustry #QualityRiskManagement #Compliance #Innovation #ProcessOptimization #PatientSafety #RegulatoryStandards #ContinuousImprovement #ChangeControl #CAPA

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Each quarter, in addition to its Country Risk Assessment map, Coface updates its Sector Risk Assessment.Coface's SRA is an assessment of 13 major sectors of the world economy, with a focus on 6 regions.Once again, the region with the highest number of downgrades is Western Europe. This situation concerns in particular the #construction 🏗️ and #pharmaceutical 💊 sectors. 👉 Find all our sector assessments in our last barometer on https://ow.ly/jVlS50OYaLu

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