At GMPKit we are developing a suite of tools that enable #biologics and #celltherapy teams to start up and scale up fast. We help you build capacity while maintaining a state of full operational control. Follow the GMPKit page to learn more.
关于我们
Use our toolkit to start and scale the right way so that your operations are safe, compliant and on schedule. We all want safe and compliant GMP Manufacturing that starts on time, ends on time, is deviation free and has complete and accurate documentation. However, the need to start up, scale up, or transform will always disrupt the steady state. These changes increases the risk that something can and will go wrong. These risks come in three areas: Business Risk: Business risks can Include delays, rework, deviations, lost batches, backlogs, regulatory compliance problems, and even in a worst case the loss of your company's right to operate. Employee Risk: Change fatigue can impact employee morale. The constant need to "build the airplane while flying it" can be exhausting to employees, people can become overwhelmed, and this can lead to burn out and attrition. Compliance and Patient Risk: Starting up and scaling up should never compromise quality. Your patients depend on good manufacturing and patient safety should never be compromised during times of change and transformation. Let GMPKit be your guide: We believe that you should never have to choose between flying the airplane and building the airplane. With the right training and tools you can do both. GMPKit is toolset developed through thousands of hours starting up, scaling up and transforming front line cGMP Manufacturing and Quality Operations. These are not generic LEAN tools targeted at a mass audience. Our concepts have been field tested and proven in high throughput biologics and cell therapy formats. They are easy to learn, easy to use, and can help you stabilize, optimize and take your GMP production to the next level. Learn more at https://gmpkit.com
- 网站
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https://gmpkit.com
GMPKit的外部链接
- 所属行业
- 制药业
- 规模
- 2-10 人
- 总部
- Seattle，WA
- 类型
- 私人持股
地点
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主要
获取路线
US，WA，Seattle
GMPKit员工
动态
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What are the best biotech blogs and who is writing them?
Anybody in my #biotech network also a blogger? Have you ever considered starting one? I would love to see what you are doing. #blogging #knowledgecapital #lifelonglearning #careerdevelopment https://lnkd.in/gkBRbjFy
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Looking to drive reliability as a strategic advantage in #biopharma?? In the complex world of biopharmaceutical manufacturing, "right first time" isn't just a goal—it's linked to your right to operate. This classic 2005 Harvard Business Review article "Learning in the Thick of It" underlines the value of continuous, on-the-job learning and adapting swiftly to challenging situations. At GMP Kit, we believe that operational learning is key to enhancing #GMP compliance and manufacturing reliability. We are actively building tools and frameworks that foster a learning culture that not only improves individual performance but significantly reduces deviations, ultimately safeguarding patient safety and product efficacy. How is your organization nurturing a culture of learning to boost reliability and compliance? #GMPKit #Biopharma #ManufacturingExcellence #ContinuousLearning #RightFirstTime Read more about fostering a learning culture ?? https://lnkd.in/gJfX7ed4
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?? Curiosity isn't just about asking questions—it's a strategic tool in #biopharma! Leaders who promote curiosity create teams that innovate and optimize processes like batch disposition. How can curiosity reshape your operations? More insights here: https://lnkd.in/ghB4TKjK #LeadershipDevelopment #Innovation #curiosity
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Predicting GMP Quality Risks at Manufacturing Sites
If you work at or support a CDMO, this video is fascinating. Shout out to Redica Systems and Jerry Chapman for sharing a new facet of regulatory intelligence. The idea of predicting quality risks with inspection data is cool, but sharing the process of how the data is collected and interpreted with human and machine learning is a glimpse into the future. Good stuff! https://lnkd.in/g8cmbpdN
Predicting GMP Quality Risks at Manufacturing Sites
https://www.youtube.com/
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Asymmetric impact tool for front line leaders (low effort, high payoff).
Looking back on my journey in biopharmaceutical operations management, the NASA pause and learn (After Action Review) stands out as my favorite tool. Its impact on fostering communication and continuous improvement is unparalleled. #Biopharma #OperationsExcellence #ContinuousImprovement https://lnkd.in/gcshyiwi