Mark Van Ert’s Post

So proud of my colleagues Patterson (Pat) Shafer and Cheryl Tan who helped author Drug Information Association's new ebook on regulatory information management (RIM). If you’re curious about expert strategies for improving regulatory performance in pharma and medical devices, you can download your copy here: https://lnkd.in/gCUbchVz Way to go, #TeamFTI!

So proud of my colleagues Patterson (Pat) Shafer and Cheryl Tan who helped author Drug Information Association's new ebook on regulatory information management (RIM). If you’re curious about expert strategies for improving regulatory performance in pharma and medical devices, you can download your copy here: https://lnkd.in/eZg-2Agm Way to go, #TeamFTI!

Master strategic thinking in Medical Affairs with our brand-new eBook, now available at 50% off. This isn’t just a book—it’s an interactive journey designed to improve your strategic skills. 💡 Use code: STPMED2025V1 🔗 Get your copy here: https://lnkd.in/dkjKC9Ph #StrategicThinking #StrategicPlanning #MedicalAffairs #SkyHealthAcademy

This is where Software/SaaS can really add value providing real time data and access to data: Quote: When it comes to CRO and CDMO partnerships, biotechs find the most value in data access and regulatory expertise" What Biotechs Want from CRO and CDMO Partnerships Free Survey Report (tradepub.com)

Do you need a primer on #MarketAccess? In this free ebook for #pharma, you can learn how to understand and influence payer policies, improve coverage and communicate with HCPs. https://ow.ly/Loog50Sir2g

#CorrectiveAndPreventiveAction (#CAPA) : One of the most important #qualitymanagementsystem elements. ⭕ #Purpose/#Importance : The purpose of the corrective and preventive action subsystem is to #collect information, #analyze information, #identify and #investigate product and #quality problems, and take appropriate and effective #corrective and/or #preventive action to prevent their recurrence. #Verifying or #validating corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for #managementreview, and #documenting these activities are essential in dealing effectively with product and quality problems, preventing their recurrence, and preventing or minimizing device #failures. ⭕ #Inspectional #Objectives : 🔸️Verify that CAPA system procedure(s) that address the requirements of the quality system regulation have been defined and documented. 🔹️ #Determine if appropriate sources of product and quality problems have been identified. Confirm that #data from these sources are analyzed to identify existing product and quality problems that may require CA. 🔸️Determine if #sources of product and quality information that may show unfavorable trends have been identified. Confirm that data from these sources are analyzed to identify potential product and quality problems that may require PA. 🔹️ Challenge the quality data information system. Verify that the data received by the CAPA system are complete, #accurate and timely. 🔸️Verify that appropriate #statisticalmethods are employed (where necessary) to detect recurring quality problems. Determine if results of analyses are compared across different data sources to identify and develop the extent of product and quality problems. 🔹️Determine if #failure investigation procedures are followed. Determine if the degree to which a quality problem or nonconforming product is investigated is commensurate with the significance and #risk of the #nonconformity. Determine if failure investigations are conducted to determine #rootcause (where possible). Verify that there is control for preventing distribution of nonconforming product. 🔸️Determine if appropriate actions have been taken for significant product and quality problems identified from data sources. 🔹️Determine if CAPA were effective and verified or validated prior to #implementation. Confirm that CAPA do not adversely affect the finished device. 🔸️Verify that CAPA for #product and #qualityproblems were implemented and documented. 🔹️Determine if information regarding nonconforming product and quality problems and CAPA has been properly disseminated, including dissemination for management review. #QA #qualityassurance #regulatoryaffairs #postmarketsurveillance #pms #iso13485 #qms #Eumdr #fda #standard #medicaldevice

Code Clarity UK’s website now has a search function so you can find the right eResource to help you build compliance confidence: https://lnkd.in/edqM9KU4 💡 Checklists 💡 Workbooks 💡 Guides 📕 A reminder that our FREE compliance eBook: “Engaging Patients to Provide Services” is available on request: hello@codeclarity.co.uk ⚖️ PMCPA Case 2974 confirms (see image) circumstances define acceptability!! #abpicode #pmcpa #compliance #pharma #patients

Download VaxTRIALS, part of Emmes Group, our sister company's eBook: https://hubs.la/Q02FfYcR0 for expert tips on navigating the complexities of regulatory and ethical approvals in vaccine trials. Leveraging their global footprint, local knowledge, and decades of clinical excellence, the eBook provides valuable strategies on expediting approvals, streamlining processes and more to help drive rapid and efficient trials. #VaccineTrials #ClinicalResearch #RegulatoryApprovals #CROpartner #ClinicalTrials

Do you need a primer on #MarketAccess? In this free ebook for #pharma, you can learn how to understand and influence payer policies, improve coverage and communicate with HCPs. https://ow.ly/RZ4k50RsZBU

We asked 30 decision-makers at mid-size-to-large biopharmaceutical companies how they currently use functional service provider (FSP) outsourcing, how they expect to use it in the future and the biggest challenge they are facing right now. In the new eBook, "The Upward Trend of FSP Outsourcing," we share our findings and discuss ways we can help our customers overcome common barriers. Download here: https://lnkd.in/dWNJ4kSu