by Thomas Agrait | Jul 22, 2019 | Audits, Biotech, Business Process Transformation, Business Transformation, CAPA, cGMP, Cost Reduction, Creativity, D-M-A-I-C-S, Diversity, Engineering, FDA, FDA Inspection, FDA New Guidelines, FDA News, Hospitality Business, Human Error, Improvement, Innovation, ISO, Leadership, Lean Six Sigma, Manufacturing, Medical Devices, NeuroGneering @ VORTEX, Outsourcing, People Engagement, Pharma, Process Improvement, Professional Development, Quality Systems, Regulatory, Risk Assessment, Strengths Psychology, Team Work, Technology, Training, VORTEX by LEC, Work-Life Balance
For more information please contact us at www.lec.guru...
by Thomas Agrait | Jul 19, 2019 | Business Decision Making, Business Process Transformation, Business Transformation, cGMP, Collaboration, Commitment, Compliance, Connection, Creativity, Curiosity, D-M-A-I-C-S, Diversity, Efficiency, Engagement, Envision, Ethics, Improvement, Innovation, Interaction, Leadership, LEC Universitas, Manufacturing, Medical Devices, Motivation, People Engagement, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Quality Systems, Respect, Rewarding, Team Work
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by Thomas Agrait | May 26, 2019 | Ethics, My own personal Opinion, Pharma, Social Responsibility
Zolgensma, a new drug approved by the FDA Friday, costs more than $2.1 million. It’s made by AveXis, a drugmaker owned by pharmaceutical giant Novartis. The federal Food and Drug Administration has approved gene therapy for a rare childhood disorder that is now...
by Thomas Agrait | May 19, 2019 | Audits, Biotech, Business Decision Making, Business Transformation, cGMP, Compliance, Computational Neuroscience, Creativity, D-M-A-I-C-S, Draft Guidance, Engagement, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News, Fear Management, Hospitality Business, Human Error, Leadership, Lean Six Sigma, Logistics, Manufacturing, Medical Devices, Mindfulness, NeuroGneering @ VORTEX, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Quality Systems, Strengths Psychology, Team Work, Technology, Training, VORTEX by LEC, Work-Life Balance
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by Thomas Agrait | May 9, 2019 | Audits, Biotech, Business Decision Making, Business Transformation, CAPA, cGMP, Computational Neuroscience, Connection, Creativity, D-M-A-I-C-S, Draft Guidance, Efficiency, Engagement, Engineering, Ethics, FDA, FDA Inspection, FDA New Guidelines, Hospitality Business, Human Error, Improvement, Innovation, ISO, Leadership, Lean Six Sigma, Logistics, Manufacturing, Medical Devices, Mitigation Strategies, NeuroGneering @ VORTEX, People Engagement, Personal Development & Improvement, Pharma, Process Improvement, Profitability, Quality Systems, Supply Chain, Team Work, Tech, Technology, Training, VORTEX by LEC, Work-Life Balance
We at Lean Enterprise Consulting provides Solutions to you and your Business! You can win a book! Just hit like & share my posts, invite your friends to join my LinkedIn Community. You will participate in the raffle of the book: “The Mind of the...
by Thomas Agrait | May 8, 2019 | Communication, Compliance, Draft Guidamce, Efficiency, FDA New Guidelines, Guidelines, Pharma, Press Release, Regulatory, VORTEX by LEC
Today the U.S. Food and Drug Administration (FDA) published draft guidance entitled “Submitting Documents Utilizing Real-World Data (RWD) and Real-World Evidence (RWE) to the FDA for Drugs and Biologics.” This draft guidance encourages sponsors and applicants who are...
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