Sylwia Pawlaczyk

Struggling with chemical inventory management and regulatory reporting? Learn how to streamline your processes and enhance fire safety https://bit.ly/3Q4JxdC #laboperations #labsafety #EHS #labcompliance

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𝙎𝙩𝙧𝙚𝙖𝙢𝙡𝙞𝙣𝙚 𝙔𝙤𝙪𝙧 𝙎𝙪𝙥𝙥𝙡𝙞𝙚𝙧 𝘼𝙪𝙙𝙞𝙩𝙨 𝙬𝙞𝙩𝙝 Eurofins | Li-Med Are you behind on your Supplier Audits? Don't stress – Eurofins | Li-Med member of the Eurofins Medical Device group is here to manage your entire audit program, ensuring you never miss a deadline again. Here's how we can support you: ✅ Supplier Coordination: We'll contact your suppliers to organize the audits seamlessly. ✅ Audit Agenda Preparation: Our team will send out detailed audit agendas to keep everything on track. ✅ Location flexibility: We offer on-site audits at your supplier's facility for your convenience. ✅ Comprehensive Audit Reports: Receive thorough audit reports, ready for inspection and review. Plus, our expert auditors will conduct training on your procedures, providing valuable insights and ensuring you are inspection-ready at all times. Don't let overdue audits cause you headaches. Contact us today to discuss how we can help keep your audits on schedule and compliant. ☎️ Salesil@bpt.eurofinseu.com #SupplierAudit #QualityAssurance #EurofinsMedicalDevice

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Are You Ready for the Digital Quality Measurement Revolution? "Six Things Your Quality Team Should Know for the Transition to Digital Quality Measurement: 1. Transition is Imminent: The transition to digital quality measurement will be here before you know it. Start preparing now to ensure a smooth changeover. 2. Data Pipeline Turnaround: Understand how long it takes for data to move to the FHIR server. Know that an "adjudication decision" is when the decision to pay or deny is made, not when payment is completed. 3. Clinical Data Sources: Ensure the source of clinical data is confirmed. All clinical data maintained by the payer must be accessible via the Patient Access API. 4. Validation Standards: Make sure your data meets HL7 FHIR R4 standards. Know if a specific implementation guide was used and if it passes validation. 5. Correct Code Mapping: Ensure major codesystems are correctly mapped. For example, ICD-10 PCS codes should be in the procedure array, while CPT and HCPCS codes should be in the item array. Know how your data is mapped to FHIR. 6. Referential Integrity: Ensure you can produce a Patient bundle that links all patient data from various systems into one cohesive bundle. Ensuring your team is ready for this transition is crucial. Need help navigating these changes? Contact us to learn how KHS can support your digital quality measurement journey. #DigitalQuality #HealthcareData #FHIR #KHS Figure 1. Referential Integrity of Patient Access API FHIR Resources

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Are Annex 1's CCS Requirements Still Challenging You? - https://lnkd.in/eKVbS3Fq - By Xenia Dimont, GMP/GDP Inspector, GMP Compliance Adviser In this article, we highlight and evaluate the latest innovations and changes compared to the previous version of Annex 1.

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How many CAPAs does it take to solve a problem? How many CAPAs have you seen thrown at a problem that is still occurring? Let’s review definitions: Corrective Action (CA) prevents reoccurrence of a failure that has already happened, meaning we won’t let it happen again (or nearly as often). Preventive Action (PA) prevents occurrence of failure from happening the first time, meaning we see potential for failure, it hasn’t happened yet, and we intend to make sure it never does. Lets focus on CA. There are three components to CA: 1️⃣ Find the root cause 2️⃣ Implement the CA 3️⃣ Ensure the CA is effective There are one of two goals we can have with a CA: ⭐️ Significantly reduce reoccurrence ⭐️ Eliminate reoccurrence When we talk about significantly reducing reoccurrence, that’s code for “statistics!” Meaning you need to show a statistically significant reduction in the occurrence rate (or forecasted rate). Elimination is typically more resource intense and not always achievable for inherent reasons or other reasonable limitations. Sometimes we talk about short-term and long-term actions, opting for the former to satisfy customers and internal metrics, and the latter to commit to a future state. You can have a short-term action that reduces reoccurrence and a long-term that either sustains that reduction or reduces it even more. Or, the short-term reduces reoccurrence and the long-term eliminates it. So then, when deciding a CA, also understand if you’re reducing or eliminating. This helps set expectations and gets alignment upfront; nobody likes hearing, “I thought we fixed this problem! We made a commitment to the customer. Explain to me why it happened, again.” The very real answer might be that the selected CA didn’t facilitate elimination, by design, only a reduction. Have that alignment conversation early on before it turns into a difficult conversation later. Let’s rephrase the original question: how many CA INITIATIVES are needed to meaningfully address a problem? If it’s effective, just one (possibly consisting of several individual CAs). Further CA initiatives need to have another step in significantly reducing the rate and, subsequently, reducing risks as-far-as-possible, or finally achieving elimination. The hard truth: when we commit to performing an RCA and implement a CA time and time again for the same problem, we’re not conducting succesful RCAs or developing effective CAs…in fact, they’re not a CA at all, they’re just ineffective actions treating symptoms instead of root causes. And nobody feels good about that. It erodes trust, confidence, morale, and the only thing prevented is growth. It’s easy to concentrate on one or two jars. Easier still, celebrating the false sense of winning by filling the jar. Fill your problem jar with just a few meaningful and effective corrective actions instead of filling it with disparate ineffective actions. After all, there are many more jars that need some CAPA marbles!

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[Regulatory and Toxicological of Cosmetic Products in North America] Ensuring the safety and compliance of cosmetic products in North America involves navigating complex regulatory frameworks in both the United States and Canada. Here's a brief overview of the key requirements:   UNITED STATES ◾ Formula Review: The main point is to comply with the FDA regulation such as the restricted ingredients list or the positive colorants list. The USA being a federal state, each state may have set up local regulations applicable to specific territories. One of the best example is the California Proposition 65. This regulation mandates the disclosure of chemicals known to cause cancer, birth defects, or other reproductive harm.    ◾ Label Check: Labels must adhere to the Fair Packaging and Labeling Act (FPLA) and the FDA Labeling Guide. This ensures that consumers have clear and accurate information about the product. Besides, the California Proposition 65 requires warning labelling if the product contains listed chemicals.   ◾ Registry of Facility & Products: Since July 1st, facilities and products must be registered through the Cosmetics Direct portal (FDA Portal). This enhances transparency and traceability in the supply chain.   CANADA ◾ Formula Review: Ingredients must be vetted against Canada's Hot List of Ingredients, which outlines substances that are restricted or prohibited in cosmetic products.   ◾ Label Check: Proper labeling is essential to meet Canadian regulatory standards, ensuring products are safe for consumers and compliant with national laws.   ◾ Cosmetic Notification Form (CNF): Before a product can be marketed, a Cosmetic Notification Form (CNF) must be submitted. This notifies Health Canada of the product's ingredients and ensures compliance with Canadian regulations.   Navigating these regulations is critical for ensuring the safety, quality, and marketability of cosmetic products in North America. Eurofins Cosmetics & Personal Care is here to offer you personalised support for your compliance procedures on this market.   Contact us ➡ https://lnkd.in/frxdUDg   #eurofins #cosmetics #regulations #canada #US #GlobalExpertisePersonalTouch

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🔬 Facing a Lab Incident? Here’s Your Action Plan You've just encountered an unexpected alarm during your lab analysis—what next? Incidents like these aren't uncommon, and they're certainly manageable. Here's a structured approach to handle such situations while adhering to GMP standards: - Stay Calm: It’s critical to remain composed. Panicking can cloud judgment and delay resolution. Remember, lab incidents are a part of the scientific process. - Locate and Assess: Quickly identify where the alarm is coming from. Follow any immediate instructions displayed on the instrument. Consulting the instrument log can provide crucial insights into the alarm's nature and help prioritize your next steps. - Embrace the Learning Curve: Rather than fearing lab incidents, view them as learning opportunities. Each event contributes to the collective experience and knowledge of the lab team. - Document Thoroughly: Record every detail of the event. This will not only aid in understanding the incident but will also serve as a learning tool for future reference. - Review and Implement CAPA: Post-incident review is where the growth happens. Evaluate the root cause thoroughly and develop a Corrective and Preventive Action (CAPA) plan. This is your chance to strengthen lab practices and minimize future occurrences. Remember, each incident in the lab is a stepping stone towards enhancing our safety protocols and quality control measures. Embrace them as part of your professional growth and contribution to maintaining a high standard in the GMP environment. Read more about CAPA: https://lnkd.in/dG95wNbR #GMPInsiders #CAPA #LabIncidents #GMPWeeklyHumour

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Part II of the article on design controls that depicts how to integrate design control and risk management process. #Risk Management # Design Controls

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🤔🔍 What are the updated requirements in ISO 15189:2022 regarding External Quality Assurance (#EQA) for labs? How are you incorporating these requirements in your lab and does your EQA provider take these into account? Let us know in the comments below! #ISO15189 #lab

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Corrective and preventive action (#CAPA) processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement. https://lnkd.in/dDdYAXEP Cencora | Pharma solutions #QMS #clinicalresearch

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🌐 The Eurofins network is built on trust. Our clients expect the highest level of integrity and competence from each Eurofins entity and employee.   ⚖️ Compliance with all relevant regulations is enhanced by embedding the value of integrity in the culture of our organization.   📝 Read about the Eurofins network’s framework for transparency, accountability, and ethical decision-making in the ‘Governance’ section of our ESG Report 2023: https://lnkd.in/drriKtEh   #Eurofins #ESG #Governance #Sustainability #TestingForLife

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Are Annex 1's CCS Requirements Still Challenging You? Xenia Dimont, a GMP/GDP Inspector at GMP Compliance Adviser reviews the revised Annex 1 of the EU #GMP Guide with the main focus on highlighting and evaluating changes compared to the previous version of Annex 1. In summary, it highlights the following significant innovations: - integration of ICH Q10 (Pharmaceutical Quality System) - integration of ICH Q9 (Quality Risk Management) - need for a holistic, site-wide contamination control strategy (CCS) - adoption of new technologies (e.g., rapid microbiological methods) emphasizing the relevance of barrier technology and differentiating between various barrier systems - inclusion of two new sub-chapters on form-fill-seal and single-use systems (SUS) #eugmp #ichq9 #ichq10 https://lnkd.in/e5g_ZTJ8

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A variety of regulations are calling for more due diligence and transparency in supply chains. Traceability provides visibility into a #product’s journey, enabling product authentication and verification of sustainable and ethical practices. Read our path forward here: https://bit.ly/3xfPBd8 Authors: Adrian Kirste, Sree Kancherla, Frederic Dittmar, and Christina Carlson

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⚡ Cleaning Validation Tip: Based on guidance from the FDA, the life cycle approach should be considered best practice when implementing a cleaning validation process. Nonspecific methods, such as TOC, comply with the best practice recommendation by measuring the total contaminants in the cleaning process rather than just a specific API. Learn more in our eBook! https://bit.ly/3UxS1eL #SieversInstruments #ContaminationControl #Accuracy #TOC

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✅ Understanding Challenge Tests in Cosmetics: Regulatory Significance and How CE. way Can Help👩‍🔬 Challenge tests in cosmetics assess product preservation efficacy by simulating microbial contamination scenarios, ensuring safe and stable use. Challenge tests are crucial in ensuring product safety in the cosmetics industry. They are required by regulatory bodies and align with international standards to protect consumer health. Without these tests, there is a high risk of introducing potentially harmful products into the market 🚫🤢. Therefore, challenge tests significantly maintain product safety and quality in the cosmetics industry 💄👍. CE.way offers specialized support to ensure your cosmetics exceed safety & quality expectations. Our expertise guides you through regulatory challenges. Partner with us to ready your products for any challenge. 💄💪🏼👨🏻‍💼👩🏽‍💼. #Cosmetics #ChallengeTests #CEway #ConsumerSafety #Regulation #Beauty #Producttesting #safety

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Sunday ≠ rest day. At least not for our ESRs. Today, 4 ESRs will be presenting their work at #ESTRO24: 10h30 in “QA and auditing: Dose measurements and machine QA”: - Sergei Diuzhenko (Cosylab): Dosimetric impact of deviations in machine delivery parameters ⚙️   10h30 in “Intra-fraction motion management and real-time adaptive radiotherapy”: - Stefanie Bertschi (OncoRay): Online-adaptive proton therapy: Feasibility of prompt-gamma verification for CBCT-based adapted plan💫   16h30 in “Image acquisition and processing 2”: - Arthur Jr. Galapon (UMCG): Towards clinical sustainability of deep learning-based sCT models after CBCT image software upgrade 🏩 - Giuliano Perotti Bernardini (UMCG): AI-enhanced proton radiography: deep learning for assessing treatment deviations in proton therapy🤖   See you there. #MSCA #ESTRO2024 #Horizon2020 #ProtonTherapy

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From AllTopStartups: The Future of Quality Management: Emerging Trends in QMS Technology ------------------------------- Successful businesses have always chased higher quality. However, technological advancements and increased customer demands are causing a paradigm shift for traditional Quality Management System (QMS).  This article delves into the… The post The Future of Quality Management: Emerging Trends in QMS Technology appeared first on AllTopStartups . #entrepreneur #startups #learnbusiness #techstartups #marketingtips #emailmarketing #businesstools #marketingstrategy #businessowner #startupbusiness #startuplife

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