Chip Bennett, PMP

Struggling with timely closure of open deviations? We know how challenging this can be, especially when your technical and quality teams are focused on ongoing operations. Did you see our latest article, "Biopharmaceutical Quality and Compliance: Navigating Good Manufacturing Practice Deviations," authored by Anthony Newcombe in BioProcess International, May 2024? Applied Biopharm Consulting can help to manage a backlog of deviation investigations and closures, support batch release, PPQ execution and meet site KPIs. Connect to discuss how we can support your needs (before the holiday season). #qa #deviations #quality #qms #gmp #consulting

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Companies often struggle to upgrade QMS and seek modern technologies to accurately identify root causes and implement effective CAPAs. SECA offers intelligent tools and techniques that efficiently help organizations overcome these persistent challenges. If you're experiencing similar issues, book a demo today! #innovation #technology #investigations #linkedin

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🔬 Facing a Lab Incident? Here’s Your Action Plan You've just encountered an unexpected alarm during your lab analysis—what next? Incidents like these aren't uncommon, and they're certainly manageable. Here's a structured approach to handle such situations while adhering to GMP standards: - Stay Calm: It’s critical to remain composed. Panicking can cloud judgment and delay resolution. Remember, lab incidents are a part of the scientific process. - Locate and Assess: Quickly identify where the alarm is coming from. Follow any immediate instructions displayed on the instrument. Consulting the instrument log can provide crucial insights into the alarm's nature and help prioritize your next steps. - Embrace the Learning Curve: Rather than fearing lab incidents, view them as learning opportunities. Each event contributes to the collective experience and knowledge of the lab team. - Document Thoroughly: Record every detail of the event. This will not only aid in understanding the incident but will also serve as a learning tool for future reference. - Review and Implement CAPA: Post-incident review is where the growth happens. Evaluate the root cause thoroughly and develop a Corrective and Preventive Action (CAPA) plan. This is your chance to strengthen lab practices and minimize future occurrences. Remember, each incident in the lab is a stepping stone towards enhancing our safety protocols and quality control measures. Embrace them as part of your professional growth and contribution to maintaining a high standard in the GMP environment. Read more about CAPA: https://lnkd.in/dG95wNbR #GMPInsiders #CAPA #LabIncidents #GMPWeeklyHumour

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If you’re an organization seeking guidance for integrating #DataIntegrity into your #QualitySystem to ensure #RegulatoryCompliance, our experts shed light into key considerations and cover ALCOA++ principles in our latest post.  https://hubs.ly/Q02vBnpk0

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Quality Compliance Need help ensuring your root cause analysis for OOS batches pass muster with the Agency? Or why your Quality Program is getting repeat observations despite internal oversight? Give KTK a call and have one of our industry experts previously employed by the FDA and industry operations help you get your Quality program back in compliance!

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Misconception: Validation is a one-time process. Reality: Monitoring and control systems for Continued Performance Qualification (PQ) are essential to ensure the ongoing integrity of your cold chain. Regular checks and adjustments help catch issues before they impact product quality. Learn more about the importance of PQ and how to implement effective monitoring systems. 🔗 Read more: https://hubs.la/Q02GZYdj0 #coldchain #validation #PQ #qualitycontrol #ModalitySolutions

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Don't navigate the regulatory world alone. RAPS books are written by expert authors who are committed to providing you with essential knowledge. Browse our collection here: https://bit.ly/4aRsFPB

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Get this practical guide to current GMP guidelines including EU GMP Annex 1. It starts by explaining the requirements, then breaks down what that means to you in your manufacturing facility. The book is broken into 3 sections: - fundamentals - applications - solutions. Get this e-book today: https://bit.ly/3qz4d4b

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Struggling with chemical inventory management and regulatory reporting? Learn how to streamline your processes and enhance fire safety https://bit.ly/3Q4JxdC #laboperations #labsafety #EHS #labcompliance

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Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities. 

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The FDA's Center for Drug Evaluation and Research has released its latest report on the state of pharmaceutical quality. This report is a comprehensive overview that sheds light on the agency's efforts to ensure the safety, efficacy, and quality of drugs available to patients. In the report you can find topics including: -Trends in manufacturing quality and compliance. -Efforts to modernize manufacturing technologies. -Strategies to address challenges in global drug supply chains. Check out the full report below #PharmaceuticalQuality | #FDA | #DrugSafety | #RegulatoryCompliance #Healthcare | #CDER | #QualityAssurance | #IndustryInsights

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Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities.

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Having a master validation plan in place will help inspectors identify validated and verified activities during an inspection at your company, according to FDA officials. Jeff Craven reports in Regulatory Focus ✅ 📣 https://bit.ly/4bhzZEm

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[new guest post] Here's how to train your biologics quality team to reduce compliance risk: https://hubs.la/Q02BDC8V0 by Sarah Boynton, MBA at Quality Executive Partners, Inc. (QxP®) #pharma #humanresources #qualityassurance

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Written with both newcomers and seasoned professionals in mind, our “QbD & PAT for dummies” handbook is there to simplify the intricacies of #ProcessAnalyticalTechnology (PAT) and #QualityByDesign (QBD), to help you deepen your understanding of PAT applications and begin the journey towards revolutionising your manufacturing approach! Download your free copy here: https://lnkd.in/epnDGV6D #DigitalTransformation

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Ready to streamline your IND and BLA submissions for biologics? Our latest blog provides key considerations and best practices to ensure compliance and facilitate timely approvals. Learn how early FDA engagement and meticulous documentation can make all the difference. https://lnkd.in/eDnazMwc #FDA #IND #BLA #Submissions #Freyrsolutions #Pharmaceuticals #Biologics

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Hey everyone, Darren Reeves here with another DP Minute! Today, we’re diving into the QMSR Preamble Comment #40.The comment suggested that the QMSR should include a definition of "critical supplier" as defined in MDSAP. Watch the video to see how the FDA responded, and to understand the expectations in the QMSR of medical device manufacturers related to supplier evaluation and identifying who their critical suppliers are (including consultants). Our DP Minutes are created to help you navigate the nuances of medical device regulations. Have questions or want to dive deeper? Visit DPDConline.com for more insights and connect with us on LinkedIn to join the conversation. #QMSR #ISO13485 #FDA #MedicalDevices #DPDConsulting #MedicalDeviceRegulatoryConsulting #SupplierEvaluation #MedicalDeviceManufacturing #DPDC #MedicalDeviceConsultation

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Medical device manufacturers this is for you. Watch the video to see how the FDA responded, and to understand the expectations in the QMSR of medical device manufacturers related to supplier evaluation and identifying who their critical suppliers are (including consultants). #medicaldevice #medicaldevicedmanufacturer #criticalsupply #FDA

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AAMI has officially released TIR48, a new guidance document that will help manufacturers navigate FDA's Current Good Manufacturing Practices (CGMPs) related to combination products. It addresses risk management, quality policy, inspection readiness, and compliance pathways for 21 CFR. Get the latest on the guidance and what these means for you! #medicaldevices #regulatorycompliance #combinationproducts https://lnkd.in/encewHfd

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