Greg Lundell

Headed to ISPE Delaware Valley Chapter (ISPE DVC)'s annual symposium tomorrow? Swing by Booth 1203 to meet our team and talk through your biggest engineering or automation challenges in #pharmaceuticalmanufacturing. Not only do we want to meet you, we want to enter you to win FREE football tickets! See you tomorrow! #pharma #biopharma #ISPE #knowitbeforeyoubuildit #CQV #processengineering #automation #digitaltransformation

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Headed to ISPE Delaware Valley Chapter (ISPE DVC)'s annual symposium tomorrow? Swing by Booth 1203 to meet our team and talk through your biggest engineering or automation challenges in #pharmaceuticalmanufacturing. Not only do we want to meet you, we want to enter you to win FREE football tickets! See you tomorrow! #pharma #biopharma #ISPE #knowitbeforeyoubuildit #CQV #processengineering #automation #digitaltransformation

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AAMI is pleased to announce that the FDA has added three ISO standards and two AAMI adoptions of these standards to its database of Recognized Consensus Standards. The sterilization standards just added to the database are ANSI/AAMI/ISO 11140-1:2014 and ANSI/AAMI/ISO 13004:2022. FDA’s recognition of these standards is a major step forward for both AAMI and ISO. #sterilization #sterileprocessing https://lnkd.in/eD3eQT5s

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Understanding Cleanroom Protocols: The Key to Compliance  When it comes to cleanrooms, construction and operational phases require distinct protocols. Treating them the same could risk contamination, product recalls, and regulatory penalties. Learn how to navigate these challenges in our latest blog post—essential reading for cleanroom engineers and senior leadership!  Ensure your cleanroom meets the highest standards.  https://lnkd.in/d7E7JFNE

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ARE YOUR FACILITIES READY FOR INSPECTION? #FDA expert investigator Simone Pitts recently shared her methodology for inspecting pharmaceutical manufacturing facilities, emphasizing the importance of quality systems, analytical data review, and robust cleaning validation processes. Her examples of inspection issues in cleaning programs, tablet and packaging operations, and microbiology laboratories highlight the critical need for thorough protocols and proactive quality management to prevent compliance failures. At Quality Executive Partners, Inc. (QxP®), we support pharmaceutical companies in achieving the highest standards of compliance and quality. Our consulting expertise and Virtuosi® educational platform empower teams to master these essentials, ensuring readiness for even the most rigorous FDA inspections. Learn how we can help your team excel: https://lnkd.in/ec9kZmy2 #pharma #biopharma #biotech #qualityassurance

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Ensuring compliance can be a challenge, but Dickson is here to help! Join Brian Kerslake and Ryan Lesko at the ISPE Boston Product Show on October 2nd at Gillette Stadium and discover how our advanced environmental monitoring solutions can simplify compliance for your organization. Dickson helps to provide the tools and expertise you need to maintain regulatory standards and avoid costly setbacks. #ISPEBoston #Compliance #EnvironmentalMonitoring #DicksonData

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The FDA just posted final guidance introducing a transitional enforcement policy for ethylene oxide (EtO) sterilization facility changes affecting Class III medical devices. The guidance emerges from a critical context: the EPA published a final rule in April 2024 that revised emission standards for EtO sterilization facilities, requiring many facilities to install new controls or modify their operations. EtO sterilization is used to sterilize about 50% of devices requiring sterilization in the US. The policy aims to prevent potential medical device shortages during this transition period by providing a framework for the FDA to evaluate, on a case-by-case basis, whether they will exercise enforcement discretion regarding sterilization facility changes before formal PMA or HDE supplement approval. A few key elements of the policy: 1/ Applies only to Class III devices with approved PMAs or HDEs that are single-use devices provided sterile + sterilized using EtO (either fixed chamber or flexible bag). 2/ Does not apply to: - Other sterilization methods - Changes in sterilant type - Combo products - Reusable or non-sterile devices - 510(k) cleared devices - Devices licensed under Public Health Service Act 3/ Manufacturers submit informal notification to FDA including: - Device/product details and PMA/HDE numbers - Current and proposed sterilization facility information - Timeline for implementation - Summary of any sterilization process changes - Signed affirmation of no other device changes 4/ FDA then evaluates notifications case-by-case considering: - Potential supply disruption risks - Facility compliance history - Quality system standards 5/ If FDA exercises enforcement discretion, the manufacturer can implement change before supplement approval. They must submit formal PMA/HDE supplement within 120 days and must complete validation before distribution FDA conducts an expedited review of the supplement. 6/ The policy is anticipated to last 3 years based on EPA compliance deadlines. FDA may revise, extend, or replace the policy as needed. 7/ In terms of inspection requirements, pre-approval inspections are generally not required if a site has a good compliance history. FDA may conduct post-approval inspections as needed. ——— A few recommendations here: ☑️ First, determine if this policy applies to your Class III device. ☑️ Submit informal notification to FDA at [email protected] with device details, sterilization facility information, and timeline. ☑️ If FDA grants enforcement discretion, proceed with: - Process validation at the new site - Submit formal PMA/HDE supplement within 120 days - Continue preparation for potential FDA inspection ☑️ Maintain documentation showing no changes to device design, specifications, materials, or sterilization parameters beyond the facility change. #eto #fda

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❗One day left to register! ❗ Do you work in the pharmaceutical industry? Then you need to register for Engineered System Solutions Manager Bryan A. Jensen's presentation: "Design, Install & Maintain a Pharmaceutical Compressed Air System" Wednesday, May 22 at 11am EDT 🕚 Hosted by ISPE, this presentation will cover: 🟦 ISO & ATSM standards on air quality & why they're important for equipment selection 🟦How system design and installation methods affect air quality, system efficiency and maintainability 🟦How to optimize your system with proper sizing of infrastructural subcomponents 🟦Methodology for integrating controls with data collection and regular analysis Register here to save your spot and get reminders: https://bit.ly/3QA1LE5 #pharmaceutical #compressedair

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✳️Calling all Pharmaceutical Engineer or Biotech and/or BioPharma professionals! Don't miss this year's ISPE Boston Area Chapter Product Show in one week at Gillette Stadium in Foxborough, MA. Visit AutomaTech at booth # E180 to see the latest industrial automation solutions. Why attend⁉️ ✅Gather Insights: The region’s most recognized experts share knowledge of breakthrough technologies and the latest regulations. ✅Connect with fellow professionals, strike up conversations at booths and plug in to the energy that comes from walking the show floor with 4,200+ forward-thinking peers. ✅Gain the inspiration you need to solve tough problems, identify best practices, exceed demands, guide your organization into the future and develop a competitive edge. ✅Relax, unwind and talk shop at our famous After Party! There are always fun features in store for this can’t-miss event. For more info and to register, visit: https://hubs.la/Q02Q5L0w0 #ispe #pharma #pharmaceutical #biotech #biopharma #automation #industrialautomation

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BLOG: What Are Real-time Monitoring Systems Improve your cleanroom's efficiency and reduce contamination delays with real-time monitoring systems. These systems provide continuous data, alerts, and feedback, helping your team respond swiftly to contamination events. Learn how they work, their benefits, and how to implement them to enhance your cleanroom's performance. Discover more here.

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Environmental monitoring (EM) plays a critical role in ensuring sterile compounding facilities remain in a state of control. It's not just about testing the product, but rather testing the process itself by keeping a close eye on the environment where the product is made. EM provides vital data that helps ensure contamination—especially microbial—doesn't compromise your sterile preparations. Sterility testing alone cannot guarantee a contamination-free product. A proactive approach is required, and that’s where environmental monitoring shines. By tracking and trending data over time, compounders can detect early signs of a decline in environmental quality. These trends allow for corrective actions to be taken before any safety risks arise. Staying ahead of problems is always more cost-effective than reacting to contamination that has already occurred. Learn more about EM services Eagle provides at https://bit.ly/49g62Vs #EM #EMprogram #sterilecompounding

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Did you know ISPE Guidance Documents are considered the Gold Standard in the industry? Peer reviewed and crafted by industry experts, ISPE Guidance Documents allow you to maximize your knowledge and expertise in your field. One of the many benefits of an ISPE membership includes saving $300 on your next Guidance Document purchase, as well as FREE access to over 20 good practice guides. Ready to join or renew today? Use code SPRING24 at checkout to receive an exclusive ISPE cooler backpack and hat. * Learn more about ISPE membership benefits and join now: https://hubs.la/Q02vWMTx0 #ISPE #pharma #biotech #biomanufacturing #pharmaceuticalmanufacturing

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Are You Ready For Your Next Regulatory Inspection? Are You Suffering From Inspection Stress? Read the latest blog from ZES. #FDA #MHRA #EMA #inspection #inspectionstress #pharmaceuticals #pharmaceutical #medicaldevice #manufacturing https://lnkd.in/eVbfSjKd

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🔬 Elevating Lab Performance: The Critical Role of Internal Audits in Labs 🔍 Dive into our latest blog on why internal audits matter in laboratory settings and how they uphold our commitment to accuracy and trust. Read the full blog: https://lnkd.in/dkDpBDuk National Accreditation Board For Testing and Calibration Laboratories (#NABL) #proficiencytesting #accreditation #testinglaboratory #qualityassurance #qualityexcellence #qualityservice #quality #microbiology #regulatorycompliance #LabPerformance #InternalAudits #LaboratoryStandards #ISO17025 #ISO17043

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Effective project management is crucial to the success of any laboratory installation. Learn how New England Lab's proactive approach, emphasizing attention to detail, safety, and clear communication, can deliver exceptional results on time and within budget. Read our latest blog post titled "Project Management: The Key to Laboratory Success" to discover the benefits of our client-centric project management process. Blog: https://lnkd.in/eMkwv8Jc #LaboratoryProjectManagement #NewEnglandLab

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🛑 Are you ready for the FDA inspector? If not, it's time to prepare your QMS. Join us for an insightful webinar on the 5 most common FDA violations and how to prevent them from happening in the first place! Whether you're looking to enhance your skills, expand your knowledge, or network with industry professionals, this session is not to be missed. 📅 Date: October 18 🕒 Time: 12:00 PM MST 💻 Register here: https://lnkd.in/dSDE7smR Our expert speaker, Mark Gee, will cover what the most common cited infractions are, how to prevent the infractions from occurring in YOUR business and QMS, how to respond to a 483 Letter, and how to respond to an FDA Warning Letter. 🔗 Secure your spot now, and feel free to share with your network! #Webinar #ProfessionalDevelopment #Networking #IndustryInsights #Audit #FDA #Compliance #Violations #Quality

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Are you new to working in a cleanroom? Garbing up can be a challenge in the beginning. Check out this recent article about donning and doffing cleanroom gloves with a visual chart from Kimberly Clark Kimtech, who we are an authorized distributor for. 😎😎👍🔥 https://lnkd.in/gn4G7gbi

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🔍 Seeking expert advice on FDA Pre-Approval Inspections (PAI)? Look no further! Our comprehensive article gives valuable insights on preparing for this critical stage. Stay proactive and ace your inspection! 💯📚 https://lnkd.in/eEReRUiM #FDA #PAI #InspectionPreparation

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