Eric Henry

https://lnkd.in/g4DUjp8r So does your third party monitoring program include regular audits? If so what is your definition of regular? Where in your pipeline does it kick in? This and more nags from the rejection section. Time to do your homework outside of costs to make, because there are hidden costs especially when FDA finds them.

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We're committed to helping you achieve excellence in quality management, especially in the highly regulated field of medical devices. That's why we're thrilled to announce that we're in the process of recording our new series on ISO 13485 Internal Auditing! Next will be an Overview and Executive Brief on what it takes to Implement ISO 13485. A PR campaign is beginning to go out announcing of newly designed website featuring our online training. See our post re: Internal Auditing Workshop. Why is ISO 13485 Internal Auditing Crucial? Internal audits are the backbone of an effective Quality Management System (QMS). They ensure that your organization meets the stringent requirements of ISO 13485, which is critical for medical device manufacturers to maintain compliance, improve operational efficiency, and enhance patient safety. This could prevent major issues with FDA and product recalls. Whether you lead the Internal Audit program or just audit the audit program, this is a great course. Our new series will cover: ✅ Audit Planning & Preparation: Learn how to develop a comprehensive audit plan that addresses all aspects of your QMS. ✅ Audit strategies for all of the Requirements. ✅ Conducting Effective Audits: Discover the best practices for performing thorough and objective audits that uncover non-conformities and areas for improvement. ✅ Reporting & Follow-Up: Understand how to document audit findings and implement corrective actions to drive continuous improvement. ✅ Real-World Scenarios: Get insights from experienced auditors who have successfully navigated the complexities of ISO 13485. What You'll Gain: By mastering internal auditing, you'll be empowered to: Ensure compliance with ISO 13485 and other regulatory requirements. Identify and mitigate risks proactively. Improve process efficiencies and product quality. Foster a culture of continuous improvement within your organization. 🌟 Stay Tuned! We can’t wait to share these valuable insights with you. Keep an eye out for the release date and make sure you're on our email list to get the latest updates. Join now and receive a $100 discount on your first course purchase! If your company is certified, get our Perpetual Calendar https://bit.ly/3vgYVN2 Considering getting certified, get our Process Map https://bit.ly/45uR9fn These get you on our email list ☑ Have a say in what courses to request. We can also customize. Let’s continue our pursuit of excellence together and drive your business forward with ISO standards! 💼 #ISO13485 #InternalAuditing #QualityManagement #MedicalDevices #ContinuousImprovement #Compliance #ISOStandards #ProfessionalDevelopment #InternalAuditorasaProfession

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PI's Krystal Santiago (VP Regulatory Affairs) discusses the shift towards point-of-care diagnostics and its drive to reduce test times while meeting stringent regulatory standards. Learn more about PI's regulatory expertise here: https://lnkd.in/dZKT6g2n #FDA #productdevelopment #regulatoryadvice #regulatorystrategy #regulatorystandards

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🤔 Did you know that risk analysis is the top category of issues in design controls? 👇45% of the 338 inspectional observations for design validation [21 CFR 820.30 (g)] between 2019-Sep 2024 were related to "risk analysis not performed/inadequate". 💥FDA scrutiny on design controls and risk management is only going to increase under QMSR. 👉My analysis of recent warning letters coming soon to Let's Talk Risk! ✅Sign up today to receive updates. Link in comments below. ==================== 👍Like this post? ♻️Repost and share. #letstalkrisk #riskmanagement #medicaldevices #qmsr

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The FDA has been rolling out changes with the new QMSR (Quality Management System Regulation), and there's been a lot of discussion around what it all means. If anyone still has questions, the 𝗙𝗗𝗔 𝗵𝗮𝘀 𝗷𝘂𝘀𝘁 𝘂𝗽𝗱𝗮𝘁𝗲𝗱 𝘁𝗵𝗲𝗶𝗿 𝗙𝗔𝗤 on the topic to provide more clarity. You can check it out here: 👉 https://lnkd.in/e5N78dBs On top of that, for those looking to dive deeper into the differences between the old QSR and the new QMSR, 𝘄𝗲’𝘃𝗲 𝗴𝗼𝘁 𝗮 𝗱𝗲𝘁𝗮𝗶𝗹𝗲𝗱 𝗰𝗼𝗺𝗽𝗮𝗿𝗶𝘀𝗼𝗻 𝘁𝗮𝗯𝗹𝗲 available for download. It also highlights how ISO 13485 fits into the equation. 👉 https://lnkd.in/eESmKAtR Between these resources, you should have everything needed to stay on top of the latest regulatory updates! #FDA #QMSR #ISO13485 #RegulatoryUpdates #MedicalDevices

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🚀 FDA LDT Final Rule Free Resource 🚀 There are two distinct stages of Quality System Requirements: ✅ Stage 1: Complaint Files. This is pre-QMSR.  Quality Management System Regulation (QMSR) is a new regulation incorporating ISO 13485: 2016 into the QS Regulation (21 CFR part 820) & comes into effect on February 2, 2026. ✅ Stage 3: Design Controls, Purchasing Controls, Acceptance Activities, CAPA, & records Requirements. This is post-QMSR. 👉 As mentioned in the June FDA Guidance: Laboratory Developed Tests: Small Entity Compliance Guide Guidance for Laboratory Manufacturers and Food and Drug Administration Staff: "With respect to requirements regarding complaint files prior to the effective date of the amended QSR, as discussed in the preamble to the LDT Final Rule, FDA intends to exercise enforcement discretion and generally not enforce requirements under 21 CFR 820.198 for laboratories that are in compliance with Subclause 8.2.2 of ISO 13485." 👀 You can view ISO 13485 for FREE here because it is a US CFR reference standard. This will be helpful for your compliance planning for stage 1 and 3: https://lnkd.in/gbjXBtqG

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It's here. FDA's LDT Final Rule: FDA changed the scope of the phase-in of the rule. The Proposed Rule preamble described a broad-reaching removal of enforcement discretion over the vast majority of laboratory based diagnostic tests, but the Final Rule preamble contemplates significant grandfathering, additional categories of enforcement discretion that will remain operative, and the opportunity for third-party review processes. We are fielding TONS of inquiries about the impact of this rule across the diagnostic industry. The impact is far and wide, touching therapeutic development (think biomarkers and companion diagnostics), precision medicine (think chemotherapy and gene therapy), and direct patient care (think access and equity). 🔬 Will marketing applications be required? What are the timelines? 🔬 Does the developer need to register and list? Comply with GMPs and QSR? Submit MDRs? Maintain a complaint system? Manage a CAPA program? 🔬 Design controls on a lab based diagnostic test? Yikes! 🔬 Supplier controls? Wait, I buy everything RUO? 😨 See comment below ⬇ for link to the full article, and flip below ➡ for a quick overview and key questions we are assessing for clients. Yes, your Board needs to understand this. Reach out if you need a presentation guide (LDT developer, RUO developer, and Investor/Fund). DLA Piper Life Sciences Sector @thejoyfullawyer

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Is it time to re-evaluate your CAPA processes? If your CAPA management isn't up to par, you could get cited by the FDA. Inefficient CAPAs are one of the most common reasons companies receive Warning Letters. Take a look at these strategies for ensuring you have successful CAPA management. Audit your CAPA process with OQSIE. Contact us for a free quote: www.oqsie.com/contact #capa #lifesciences #qualitymanagement

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🔧 Master CAPA Systems for Quality Excellence! Are your Corrective and Preventative Action (CAPA) systems as effective as they should be? This course is your opportunity to: ✅ Understand CAPA processes and their critical role in quality management ✅ Learn how to identify root causes and implement effective solutions ✅ Enhance compliance and prevent recurring issues Don’t miss this chance to improve your organization’s CAPA systems and drive quality improvements. 📅 Seats are filling fast—book your place now! https://lnkd.in/e_MAEYGW #CAPATraining #QualityManagement #ProfessionalDevelopment #Compliance #RootCauseAnalysis

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By 26 May 2024 manufacturers transitioning legacy devices to the MDR have to put in place an MDR compliant QMS and formally apply to a Notified Body. Be aware that at the time of application, you need to provide the documentation required as per the applicable Annex (e.g., Annex IX, clause 2.1). #BSI #MedicalDevices #MDRTransition

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We thought we'd highlight one of the many guidance documents the FDA released before the administration transition since it is directly relevant to CGMP operations. The 10-page draft "Considerations for Complying with 21 CFR 211.110" focuses on ensuring batch uniformity and drug product integrity in pharma manufacturing. It addresses both traditional manufacturing approaches and emerging advanced manufacturing technologies, including continuous manufacturing and 3D printing. The guidance explains that while manufacturers must meet CGMP requirements, they have flexibility in *demonstrating* compliance. A key focus is the integration of modern control strategies, including process analytical technology (PAT) and process models, into manufacturing operations. However, the agency clarifies that while these innovative approaches are encouraged, they must be implemented alongside appropriate testing and monitoring systems — *process models alone cannot satisfy regulatory requirements.* The document applies to the manufacture of human drug products (including biologicals) and animal drug products, though it specifically excludes the manufacture of active ingredients. Here's a quick distillation: General considerations for in-process sampling and testing: - Flexibility in implementation: Manufacturers can determine appropriate testing based on drug product type and process. Testing strategies should be dictated by the nature of the drug and manufacturing processes, and sampling doesn't necessarily require the physical removal of materials. - Scientific and risk-based approach: Manufacturers should identify critical quality attributes to monitor and control. Testing should be based on a robust understanding of products and processes and use scientific rationale to determine significant manufacturing phases. - QC: In-process materials must be tested for identity, strength, quality, and purity as appropriate. The Quality unit must approve or reject materials during production, and testing should occur at the commencement or completion of significant phases. ——— Advanced manufacturing considerations: - Continuous manufacturing may have different control strategies than batch manufacturing and can make it harder to isolate in-process materials for testing. - Multiple unit operations may be considered a single significant phase, and companies must maintain the ability to evaluate materials at significant phases. - Process models can be used to monitor in-process material attributes, but *must be paired with actual testing or monitoring.* Again, don't rely solely on simply using models. - Underlying assumptions must remain valid during routine manufacturing. - Process models should incorporate process monitoring or in-process testing. The agency recommends early discussion of alternative control strategies if you consider implementing them. Comments on the draft are open until 04/07/2025. #fda

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FDA Hot Take 🔥: Labeling mistakes have led to many costly recalls. Comment # 60 on the QMSR suggests that ISO 13485 𝗳𝗮𝗶𝗹𝘀 to address how manufacturers must inspect their products’ labels. 🔎 In their response, FDA agrees that ISO 13485 does not specifically address the inspection of labeling by the manufacturer. FDA notes that 𝗺𝗮𝗻𝘆 𝗱𝗲𝘃𝗶𝗰𝗲 𝗿𝗲𝗰𝗮𝗹𝗹𝘀 are related to labeling and packaging. 👀 QMSR Section 820.45(a) now requires that manufacturers inspect their labeling and packaging for accuracy 𝘱𝘳𝘪𝘰𝘳 𝘵𝘰 𝘳𝘦𝘭𝘦𝘢𝘴𝘦 to include: (1) The correct unique device identifier (UDI) or universal product code (UPC), or any other device identification(s); (2) Expiration date; (3) Storage instructions; (4) Handling instructions; and (5) Any additional processing instructions. Most notably, FDA singles out recalls due to 𝗮𝘂𝘁𝗼𝗺𝗮𝘁𝗲𝗱 𝗹𝗮𝗯𝗲𝗹 𝗿𝗲𝗮𝗱𝗲𝗿𝘀 that have not caught label errors. 🧐>🤖 "The requirement to inspect labeling and packaging does not preclude automatic readers where that process 𝗶𝘀 𝗳𝗼𝗹𝗹𝗼𝘄𝗲𝗱 𝗯𝘆 𝗵𝘂𝗺𝗮𝗻 𝗼𝘃𝗲𝗿𝘀𝗶𝗴𝗵𝘁." "A designated individual must examine, at a minimum, a representative sampling of all labels 𝘁𝗵𝗮𝘁 𝗵𝗮𝘃𝗲 𝗯𝗲𝗲𝗻 𝗰𝗵𝗲𝗰𝗸𝗲𝗱 by automatic readers." 🤓 "Further, automated readers are often programmed with only the base label and do not check specifics, such as control numbers and expiration dates, among other things, that are distinct for each label." Does your QMS require "human oversight" AFTER automatic label inspection❓ Please share your process 👇🏻 ~~~ If you found this interesting or helpful, consider Reposting 🔄; follow me Vincent F. Cafiso and click the 🔔 so you don't miss future content.

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𝐌𝐚𝐬𝐭𝐞𝐫𝐢𝐧𝐠 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐡𝐢𝐥𝐥 😎 Ever feel like the weight of FDA submissions, ISO 13485 requirements, and QMS audits is crushing? Not today! This is the energy we all aspire to when regulatory affairs are handled like a pro: calm, collected, and confidently prepared. 👉 Whether you're deep in compliance work or prepping for an audit, remember—the key to staying chill is preparation and a well-implemented QMS. 💡 What’s your secret to staying composed in the high-pressure world of medical devices? Share your tips below! ⬇️ #RegulatoryAffairs #QMS #MedicalDevices #ISO13485 #FDACompliance #QualityManagement

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https://lnkd.in/g6YtrbRk And so do it happens, this must be the reason why CDRH wasn’t up to par the last decade. One question. How is this going to help CDRH accomplish its inspection risk mitigation mission? Maybe the answer- farm it out to blame it on someone or something else by design of course.

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⭐ Less is more - even while being audited. Today, my colleague "AI-Auditor" had to assess a somewhat complex answer to a seemingly simple question on chapter 5.2 of ISO-13485. The question was "How does the organization currently track regulatory changes and updates that may impact operations?". The auditee's answer was: "We read through regulatory publications. If changes are identified they are noted and documented. Some risks that come out of the changes are handled properly by a person who has the experience and knowledge of the products and the technology." The AI auditor found this response to be ‘insufficient’. As a reason it wrote: "The provided answer does not fully address how the organization tracks regulatory changes and updates that may impact operations. It lacks specific details on the process and methods used to track regulatory changes, as well as the frequency of review and any mechanisms in place to ensure timely identification of changes and updates". A slightly shorter but more concise answer led to success: "The organization tracks regulatory changes and updates through industry notifications, subscription services and periodic reviews of relevant government websites." Considering the audit point in question was "The top management shall ensure the meeting of regulatory requirements." - the result also becomes quite clear. 🔑 One rule for auditees that I internalized early on was: "Never give the auditor more than he asks for." Seems to hold true also for audits performed by the AI auditor.

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Is your organization ready for an FDA inspection? FDA inspections can be stressful, but with proper preparation, you can navigate them successfully. NPG's latest white paper, "FDA Inspection Scramble: Is Your Organization Ready?" provides practical steps and insights to help you prepare effectively and avoid the last-minute scramble.   🔍 Understand the structure and purpose of FDA inspections.  🔍 Learn what to expect during and after an audit.  🔍 Discover practical strategies for inspection readiness.   Download your copy today and ensure your organization is always inspection-ready! Click the link to download: https://lnkd.in/eea9MY3g   #FDAInspection #Compliance #QualityAssurance #Pharmaceuticals #MedicalDevices #InspectionReadiness #NetworkPartnersGroup

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Update! Curious about how the FDA's Draft Guidance on PCCPs could impact your medical device updates? Discover how predetermined change control plans can streamline modifications without resubmitting through the regulatory process. Explore the details and ensure compliance with expert guidance! https://lnkd.in/eRUZk9AF Mail ID: enquiry@operonstrategist.com    Phone no: +91 9370283428   .   .   .   #FDA #MedicalDevices #PCCP #RegulatoryCompliance #510k #DeviceModifications #MedicalDeviceRegulations #HealthcareInnovation #FDAApproval #healthcareinnovations #government #medicalequipment #operonstrategist #consultation  

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FDA recalls have significantly increased over the last six years and the 🔑 to avoiding one is staying on top of quality management. Learn more about some key components of product recall avoidance in MasterControl's guide here: https://lnkd.in/e_ZhWVxr #drugrecalls #qualitymanagement #lifesciences #FDA

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