Thomas Schultze

How are you managing your GXP systems? USDM can automate and manage any GxP system in your tech stack, offering paperless validation and more. Learn more here: https://bit.ly/4doR5SH #USDMlifesciences #GxPworkflows #validation #compliance #ProcessX

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Another episode of MDRChats by ChatMDR! 🎙️ Another example showing how tools like ChatMDR can make understanding regulations so much easier, even in the form of a podcast. #MedicalDevices #MedicalDeviceRegulation #Podcast #MDRChats #ChatMDR

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Documenting the Benefit is often considered subjective but can be reinforced using real world data, scientific literature and disease state data.

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ASAPcheck uses FormFox, the largest and most trusted eCCF platform. Read on to learn how they help with drug testing programs. An eCCF is the electronic version of a Custody and Control Form (CCF) used to collect and track every drug test performed. Without an eCCF, companies can risk encountering common issues such as long turnaround times and inaccurate collection data. ASAPcheck offers our clients this option to avoid potential problems and allow for faster work while providing the following: -More accurate data that improves compliance and reduces liability. -Instantaneous transfer of data that saves time. -Secure and easily accessible data that improves drug testing management. -Streamlined digitized processes that reduce costs. -Eases administrative burden during Turnarounds by receiving paperwork digitally. Read our blog to learn more https://lnkd.in/gmqrGkbw. #drugtesting #eCCF #humanerror #ASAPcheck #safeworkplace #tangandcompany

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US FDA's UDI Requirements Discover the FDA UDI regulations (21 CFR 801 & 830) for medical devices, including labeling, GUDID submission, compliance requirements, and public health benefits. Read more: https://lnkd.in/gqGyeCCW #FDA #UDI #MedicalDevices #HealthcareCompliance #RegulatoryAffairs #MedTech #GUDID #HealthTech #MedicalDeviceRegulation #PatientSafety #MedicalDeviceIndustry #PublicHealth #MedicalDeviceLabeling #RFID #Barcoding #AIDC

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Validating Statistical Software for GxP: A Computer Software Assurance Approach 🙍‍♂️ Ian Yellowlees - Quantics Co-founder 📍 RQA International QA Virtual Conference ⌛ Wednesday May 22nd, 1:30pm BST Book your spot: https://buff.ly/44f7Ew4 Software errors can be costly, both in terms of lives and money. While you will never be able to eliminate errors entirely, systems can be designed to catch errors before they cause catastrophe. Check out Ian's talk about Computer Software Assurance (CSA), an FDA-mandated approach to programming which aims to mitigate the risk posed by bugs and other errors. Can't wait to find out more? Check out our blog: https://buff.ly/3UzBgkI #statistics #QA #RQA #QualityAssurance #FDA #validation

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(Benefit-Risk Management / Cell-based Biologics / New DRAFT Guidance on Cellular Testing) Let's start with some new vocabulary alerts for the non-cellular therapy folks like "Master Cell Bank" and "Allogenic". If you're in continuous learning mode, may want to brief thru this guidance and get your medical/scientific dictionary ready to reference. Enjoy. #fda #biologics #cber #cellbank #cellcultures #safetytesting #cgt #cellulartherapy Primer page: https://lnkd.in/e7fdMdvr

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Here are 10 Practical Tips for a Seamless QRM Implementation in CQV Processes crucial for success in the life sciences industry. Down the full White paper following this link: https://buff.ly/4cFkkQF #QualityRiskManagement #QRM #Compliance #QualityAssurance #Validation

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Find out how QMS and CTMS integration might benefit clinical studies! We examine in our blog how this integration promotes compliance and better results. Learn more: https://hubs.li/Q02ykZbb0 #CTMS #EDC #Safety #PV #eTMF #RTSM #ClinicalTrials #Cloudbyz #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #AI #Salesforce

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🧬 Viral Vector Development Trend?🧬 In recent discussions, including a few at ASGCT, I've observed a growing focus on secondary supply options and #feasibilitystudies for viral vector candidates in the #discovery - #preclinical phases. I suspect this trend underscores the importance of not only ensuring a robust supply chain but also, perhaps more importantly, optimizing the design of new vector candidates. 🥇 At DINAMIQS, we excel in both areas. Our track record of success shows that we are capable and nimble. (kudos, Eduard Ayuso and team!) Our team brings extensive expertise in #vectordesign and #optimization, empowering our clients' projects to move forward with confidence. We are committed to helping our clients navigate the complexities of gene therapy development, from enhancing supply chain resilience to refining vector efficiency and functionality. 📞 If you're exploring secondary supply strategies or seeking to optimize new candidates in your pre-clinical pipeline, let’s connect. #ViralVectors #AAV #Lenti #GeneTherapy #Biotech #Innovation #DINAMIQS #CDMO

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In the world of biopharmaceuticals, manual processes can be like fragile paper in a breeze. 🌬️ Automate your processes in terms of Good Documentation Practice to better be safe than sorry: https://hubs.ly/Q02BdJW70 📝💚 #GoodDocumentationPractice #GDP #Automation #PioneeringBiopharma

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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new FAQ! Do you have a SDTM ADaM question? The project is answering 'Naming Convention for Split RS Domain'. View this question and response via Validation/Conformance Rules page: https://lnkd.in/eGSgih7D. See what has been answered so far here: https://lnkd.in/eBUzmiNw and submit your questions to workinggroups@phuse.global. #PHUSE

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Find out how QMS and CTMS integration might benefit clinical studies! We examine in our blog how this integration promotes compliance and better results. Learn more: https://hubs.li/Q02yl0dF0 #CTMS #EDC #Safety #PV #eTMF #RTSM #ClinicalTrials #Cloudbyz #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #AI #Salesforce

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EMA has recently released the CTIS Sponsor Handbook, a comprehensive compilation of essential guidance, technical information, recommendations, and references crucial for preparing for the implementation of CTIS. This resource will undoubtedly be invaluable for sponsors navigating the complexities of CTIS. #EMA #CTIS #SponsorHandbook #Guidance #TechnicalInformation

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Compliance Mondays:  Manufacturing Quality Managers - Are you struggling to navigate the complexities of #GDPR compliance while maintaining a robust Quality Management System? Look no further! Compliance Group Inc #QMS seamlessly integrates #GDPRrequirements within Your System and helps to ensure efficiency, security, and regulatory adherence. Check out this insightful article on GDPR Compliance in #ClinicalTrials:  https://lnkd.in/gYgAVNEt Visit us at https://lnkd.in/gXZQ-cHc   to learn more about how Compliance Group Inc's services align at the forefront of navigating the Clinical Trials   Please send your questions to info@complianceg.com  #compliance #healthcare #regulation #industryinsights #medicaldevices #lifescience #complianceg #cgservices #clinicaltrials #gdpr #pharma #biotech  

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