SCC – Scientific Consulting Company GmbH’s Post

Check out this webinar on “How to ensure compliance with Annex 1”. Key learnings include: 𝗞𝗲𝘆 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴𝘀: ➡️ QRM; ➡️ CCS; ➡️Case study examples of aging facilities; ➡️ Annex 1 Gap assessment and remediation plans – a step-by-step approach. Learn about challenges  and how to have a structured approach to guide them through the assessment based on our experience in the industry. Register and access the webinar recording here: 🔗 https://bit.ly/3t850ue #CencoraPharmalex #Annex1 https://lnkd.in/eMkQKeMe 

🔬 ISO/IEC 17025: Elevating Standards in Forensic DNA Analysis 🔬 In the world of forensic science, ISO/IEC 17025 plays a pivotal role in ensuring the quality, credibility, and reliability of DNA analysis performed in forensic laboratories. Here’s why it matters: 🔑 Key Contributions: Quality Assurance: Provides a framework for consistent, valid, and reliable laboratory results, crucial in high-stakes forensic cases. Competence & Credibility: Accreditation proves a lab's technical capability, boosting its trustworthiness in court and with law enforcement. Standardization of Procedures: Minimizes variability, ensuring DNA results are comparable across labs and jurisdictions. Repeatability & Reliability: Ensures forensic labs can produce consistent results, a must for evidence presented in legal proceedings. Regulatory Compliance: Many countries require ISO 17025 accreditation for forensic labs, supporting international collaboration and recognition. Continuous Improvement: Encourages labs to evolve with advancements in DNA analysis techniques, staying at the forefront of forensic science. Risk Management: Helps prevent contamination and other risks that could compromise the integrity of forensic evidence. In short, ISO/IEC 17025 is indispensable in ensuring the scientific rigor and trustworthiness of forensic DNA results, reinforcing public confidence in the judicial system. #ForensicScience #DNAAnalysis #ISO17025 #QualityAssurance #Forensics #ForensicDNA #Accreditation #RiskManagement note the image is AI generated

Did you know that compliance with USP <665> is expected by 2026? This chapter provides crucial guidance on the analytical testing of single-use systems (SUS) to mitigate risks associated with extractables and leachables (E&L). With the deadline fast approaching, it's essential for drug developers to start preparing now. Download our white paper with comprehensive insights on USP <665> compliance. Get expert insights, detailed risk assessments, and practical steps for seamless compliance. Unlock the full document: https://lnkd.in/efB9nPUD

#Webinar - 𝗛𝗼𝘄 𝘁𝗼 𝗘𝗻𝘀𝘂𝗿𝗲 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝘄𝗶𝘁𝗵 #Annex1 🗓️ December 6th, 2023 - 10am EST, 3pm GMT. EudraLex Volume 4, Annex 1 “𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞 𝐨𝐟 𝐒𝐭𝐞𝐫𝐢𝐥𝐞 𝐌𝐞𝐝𝐢𝐜𝐢𝐧𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬” was completely revised and published in August 2022 with the expectation that Companies would be compliant per August 2023. This looks like plenty of time to assess the level of #compliance and come up with a remediation plan to close potential gaps. However, Organisations still struggle how to make this assessment, in particular for Small Medium Enterprises (SMEs). This webinar will discuss these #challenges based on our experiences within the industry and how companies can have a structured approach helping them to make the assessment. 𝗦𝗽𝗲𝗮𝗸𝗲𝗿𝘀: o Patrick Nieuwenhuizen, Director Principal Consultant at Pharmalex o Londa R., Quality Director, Quality Management & Compliance at PharmaLex 𝗞𝗲𝘆 𝗹𝗲𝗮𝗿𝗻𝗶𝗻𝗴𝘀: o QRM; o CCS; o Case study examples of aging facilities; o Annex 1 Gap assessment and remediation plans – a step-by-step approach; 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗵𝗲𝗿𝗲: 🔗 https://lnkd.in/e7pyExR6

Thanks to my fantastic colleagues Gro Haarklou Mathisen, Gunn Vist, Trine Husøy, Camilla Svendsen, and everyone else I seem to be getting involved in a *lot* more qualitative research than I ever thought I would. Next cab that just left the rank is the protocol for our planned terminology cross-walk exercise, to map the concepts used in systematic review onto those used in chemical risk assessment. This is to help two communities that talk about issues such as "relevance" and "external validity" understand where their respective terminologies line up - and where they don't. https://lnkd.in/eDy5gAze

Baker Botts is proud to be participating in the TSCA Developments 2024 virtual conference tomorrow. Partner Alexandra Dapolito Dunn will be speaking during a session titled "Risk Evaluation Framework Rule" that will discuss the following topics: - Overview of EPA’s 2023 proposal to revise its 2017 rule for conducting risk evaluations of existing chemicals under TSCA Section 6 - How EPA will incorporate transparency, flexibility, and science into the rule - Updates to the Manufacturer Requested Risk Evaluation process - Business and environmental group reactions to EPA’s proposal Learn more: https://okt.to/CqgI7d

Looking forward to tomorrow's talk on the EPA's Risk Evaluation Framework Rule...with great thanks to Elie Kommel for the work on the slides I'll be using! Come listen to the latest in TSCA updates tomorrow! It's not too late to register and hear from many experts! #environmentallaw #tsca #riskmanagementframework

Recently, I identified a pivotal error with a client's project: they had incorrectly determined their 'worst-case scenario' for biological risk assessment. This discovery led us to realign their approach to ensure their submission aligns with current standards and the state-of-the-art, crucial for both risk analysis, biological risk assessment, and clinical evaluation. Addressing this error early saved the client a significant amount of time and resources while also speeding up their CE marking submission process. I can’t stress more the importance of accurately defining and validating the worst-case scenario. A well-structured biological risk assessment report, adhering to ISO standards (like the ISO 10993-1), is pivotal for a successful clinical evaluation, proving device safety and efficacy. 👇 Have you encountered similar hurdles? Share your experiences, and let's discuss strategies for success. #medicaldevices #biologicalriskassessment #clinicalevaluation

📣 The Assessment of Regulatory Need (ARN) is a tool that facilitates the anticipation of potential regulatory actions, encouraging industry engagement in the process and proactivity in updating dossier information.   🤝 FEICA supports the joint recommendation co-signed by DUCC. The recommendation effectively educates stakeholders on the nuances of ARN, shedding light on its purposes, application, and contextual usage.   👁 Access the recommendation at this link: https://lnkd.in/e7Qar_Mw.   #ARNs #testmethods  

Certain regulatory topics are ever relevant! Last week we had the honour of participating in the TOPRA Sweden meeting in Uppsala. The presentation given by Arex Advisor’s Josephine Ingemarsson concerned PSURs – Periodic Safety Update Reports – focusing on regional and global specifics, as well insights into how the reports are assessed. Other subjects raised included lifecycle management strategies and experiences in repurposing. Rolf Eriksson summarises overall takeaways as follows: 💡 Lifecycle management requires well thought-out strategies regarding supply, risk management, line extensions and more. 💡 Periodic safety reports require global planning and coordination in all markets concerned. 💡 Repurposing is an on-trend yet challenging area when it comes to incentives and return of investment.                            Would you like to talk Regulatory? Get in touch at [email protected] #arexadvisor #regulatoryaffairs #topra #safetyreporting