Kimberly Wallbank, MBA, CQA

CGT analytical assays seek to gain information on critical quality attributes (CQAs) - but because of the nature of CGTs and its current regulatory maturity, there is no defined standard. https://lnkd.in/e34DFSTK

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Let us build your SOPs DArcy Compliance Consulting for Life Sciences builds SOPs to drive compliance, consistency, and performance. Let’s discuss how DArcy can develop the SOPs auditors want to see. https://lnkd.in/ezEHgmQZ DArcy Compliance Consulting – We get Start-ups. It’s all we do. #sop #sops #compliance #gxp #quality

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🔍 Did you know? Atlas-Compliance offers the most comprehensive and reliable FDA Investigator database on the market today. Download unlimited FDA investigator reports that are updated EVERY single week. Here is what you'll find: 🔵 Total inspections by investigator 🟡 Inspection outcomes 🔵 Trends from the last 10 inspections 🟡 Active locations 🔵 Number of warning letters & 483s issued 🟡 Download 483s and EIRs 🔵 Average inspection length (in days) 🟡 Co-inspectors involved 🔵 Trend analytics 🟡 Inspector reports since 2004 🔵 Trend analytics Don't be caught off guard when the FDA comes knocking —prepare with the data that matters! #FDA #FDAInspector #FDAcompliance #QualityAssurance #483 #WarningLetter #InspectionReady

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We’re excited to share some highlights from the RAPS Convergence 2024, where our VP of Quality and Regulatory, Dave Petrich MBA, RAC had an amazing experience! Here are some of the key takeaways that truly resonated with us:   Embracing AI in Regulatory Practices:  The discussions around how artificial intelligence can transform regulatory processes were nothing short of inspiring. Artificial Intelligence (AI) was an exciting, featured topic at RAPS Convergence its high potential applications as part of medical devices and how to improve the efficiency of regulatory operations.   Home as a Healthcare Hub: The FDA and other presenters discussed a major trend of shifting healthcare to homes. Many new products, including software as a medical device, are being developed for home use. The FDA also discussed patient-centered care approaches to improve diversity and inclusion in clinical studies and future healthcare diagnosis and treatment.   Collaboration Across Stakeholders:  It was fantastic to see regulators and industry leaders, including the FDA and EMA representatives, come together to tackle shared challenges. The focus on advancing health equity and proactive risk management really stood out and aligns with our mission to ensure that no one is left behind accessing essential healthcare technologies.   Building Community/Convergence:  The opportunity to connect face-to-face with colleagues was invaluable. Our sense of community reminded us of the importance of building strong professional relationships within the regulatory field. There are still significant differences in global regulatory requirements, but the FDA and other National Competent Authorities (NCA) are actively converging on common approaches to regulate medical devices, IVDs and pharmaceutical products.       Case for Quality:  The proactive approach to risk management, including the voluntary Case for Quality pilot program, really struck a chord. We’re passionate about fostering a culture of quality and seeing the positive impact it can have on our industry.   RAPS Convergence 2024 was a fantastic opportunity for growth and connection! David’s enthusiasm for advancing the regulatory field shone throughout the event, and he’s eager to continue these important conversations as we look forward to RAPS Convergence 2025 in Pittsburgh.   At Landrich Group, we’re dedicated to helping our clients successfully bring their medical devices and pharmaceutical products to market. Dave and our passionate team of clinical professionals are here to partner with you every step of the way. Don’t hesitate to reach out at [email protected] to share your ideas—we’re excited to help turn them into reality!   #RAPS2024 #RegulatoryAffairs #QualityManagement #AIinRegulation #LandrichGroup #ClinicalResearch

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We're ready to dive deep into regulatory intelligence this June. The RAPS Regulatory Intelligence Conference is a targeted deep dive into the most pressing regulatory intelligence and policy best practices and challenges. Join us to arm yourself with insights to prepare for the challenges ahead: https://bit.ly/4bvvgzg

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✨ Staying Compliant: Navigating Regulatory Changes in CQV Part 2 ✨ As regulations evolve, staying compliant can feel overwhelming—but it doesn’t have to be. In this article, we break down best practices and strategies that help your organization stay ahead, from real-time monitoring systems to automated documentation. PharmEng Technology empowers you to streamline your validation processes, protect data integrity, and meet evolving regulatory demands with ease. Our solutions include: 🔹 Automated Documentation Systems – Say goodbye to manual errors and ensure seamless traceability. 🔹 Real-Time Monitoring Tools – Maintain continuous compliance and enhance predictive maintenance. 🔹 Centralized Electronic Data Management – Simplify reporting and control document versions effortlessly. 📖 Read the Full Article: https://lnkd.in/gEQrTMte Ready to take the lead in compliance? Let PharmEng Technology be your partner in driving efficiency, compliance, and success. Let's get started—reach out to us at [email protected] today! 💡

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👉 #LifeSciences Quality and Compliance Professionals: Do you ever wish it was easier to make the business case for investing in a Quality Culture? Don't miss what is sure to be an actionable discussion with former FDA Investigator and current CREO Director of Quality and Regulatory Services, Vincent F. Cafiso, on how to calculate the cost of quality in life sciences. Register here: https://hubs.la/Q02M7h380 #qualityassurance

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CDRH Proposed Guidances for 2025 published today- this is a long post 😆! 🚀 Multiple LDT-related guidances on the A-list: FDA is not slowing down! 🚀 Third Party Review Organizations will be a key resource for FDA 🚀 AI-enabled devices PCCP: perfect case study for PCCP 🚀RWE to support medical devices: consider RWE for clinical validity https://lnkd.in/e7KVRs-8 Intent to Finalize: ✍ 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review (revision) ✍ Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency ✍ Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff ✍ Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 ✍Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls ✍Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions ✍Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act ✍Registration Fee Waiver for Certain Small Businesses Undergoing Financial Hardship ✍Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision) ✍Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision) ✍Validation of Diagnostic Tests for Emerging Pathogens following a Declaration and Determination under Section 564 Intent to Draft (if resources): ✍Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management Considerations and Pre-market Submission Recommendations ✍Enforcement Discretion Policy for Certain Laboratory Developed Tests for Unmet Needs: Frequently Asked Question ✍Enforcement Discretion Policy for Premarket and Other Requirements for NIOSH-Approved Air Purifying Respirators ✍Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies) ✍In Vitro Diagnostics: Labeling ✍Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (revision) ✍Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations (revision)

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Are you ready for an FDA inspection? 🔍 Act now, so you won't have to react to an FDA Warning Letter later. Register for Axeon's rebroadcast of our webinar "The Top 5 Violations Cited by FDA Inspectors & How to Prevent Them!" Learn what the most commonly cited infractions are, how to prevent these infractions from occurring in your QMS, and how to respond to 483 and Warning Letters. Your QMS can't risk a Warning Letter. Take action now to prevent it. Register here 🔗 : https://lnkd.in/gTD7Jy6f #webinar #growth #audit #inspection #FDA

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Remember the October 1 - December 31 window during which a blanket no changes submission must be sent to the FDA to keep your drug listing active.     The Regulatory Operations team at #OneSourceRegulatory is your go-to for creating, updating, and submitting all your SPL (structured product labeling) and drug listing information. We ensure compliance and address any issues promptly.     Explore our end-to-end promotional review solutions at #OneSourceRegulatory, a ProPharma company: https://lnkd.in/g8uDnu4i #SPL #RegulatoryOperations #FDACompliance #DrugListing #AdPromoReview #MLR #PRC #OSR #PPG #OSRKnowsMLR #PRCExperts #ExperienceMatters

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Remember the October 1 - December 31 window during which a blanket no changes submission must be sent to the FDA to keep your drug listing active.     The Regulatory Operations team at #OneSourceRegulatory is your go-to for creating, updating, and submitting all your SPL (structured product labeling) and drug listing information. We ensure compliance and address any issues promptly.     Explore our end-to-end promotional review solutions at #OneSourceRegulatory, a ProPharma company: https://lnkd.in/g8uDnu4i #SPL #RegulatoryOperations #FDACompliance #DrugListing #AdPromoReview #MLR #PRC #OSR #PPG #OSRKnowsMLR #PRCExperts #ExperienceMatters  

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Remember the October 1 - December 31 window during which a blanket no changes submission must be sent to the FDA to keep your drug listing active.     The Regulatory Operations team at #OneSourceRegulatory is your go-to for creating, updating, and submitting all your SPL (structured product labeling) and drug listing information. We ensure compliance and address any issues promptly.     Explore our end-to-end promotional review solutions at #OneSourceRegulatory, A ProPharma Group Company. https://lnkd.in/g8uDnu4i #SPL #RegulatoryOperations #FDACompliance #DrugListing #AdPromoReview #MLR #PRC #OSR #PPG #OSRKnowsMLR #PRCExperts #ExperienceMatters  

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Remember the October 1 - December 31 window during which a blanket no changes submission must be sent to the FDA to keep your drug listing active.     The Regulatory Operations team at #OneSourceRegulatory is your go-to for creating, updating, and submitting all your SPL (structured product labeling) and drug listing information. We ensure compliance and address any issues promptly.     Explore our end-to-end promotional review solutions at #OneSourceRegulatory, A ProPharma Group Company. https://lnkd.in/g8uDnu4i #SPL #RegulatoryOperations #FDACompliance #DrugListing #AdPromoReview #MLR #PRC #OSR #PPG #OSRKnowsMLR #PRCExperts #ExperienceMatters  

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Remember the October 1 - December 31 window during which a blanket no changes submission must be sent to the FDA to keep your drug listing active.     The Regulatory Operations team at #OneSourceRegulatory is your go-to for creating, updating, and submitting all your SPL (structured product labeling) and drug listing information. We ensure compliance and address any issues promptly.     Explore our end-to-end promotional review solutions at #OneSourceRegulatory, a ProPharma Group Company. https://lnkd.in/g8uDnu4i #SPL #RegulatoryOperations #FDACompliance #DrugListing #AdPromoReview #MLR #PRC #OSR #PPG #OSRKnowsMLR #PRCExperts #ExperienceMatters  

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