by Thomas Agrait | Sep 25, 2019 | Business Transformation, cGMP, Communication, Compliance, Draft Guidance, FDA News, Laws, Leadership, Medical Devices, Regulatory
FDA Issues Draft Guidance on Providing Regulatory Submissions in Electronic Format Today, the U.S. Food and Drug Administration (FDA) issued draft guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b)...
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Decision Making, Business Transformation, cGMP, Compliance, Computational Neuroscience, Creativity, D-M-A-I-C-S, Draft Guidance, Engagement, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News, Fear Management, Hospitality Business, Human Error, Leadership, Lean Six Sigma,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Decision Making, Business Transformation, CAPA, cGMP, Computational Neuroscience, Connection, Creativity, D-M-A-I-C-S, Draft Guidance, Efficiency, Engagement, Engineering, Ethics, FDA, FDA Inspection, FDA New Guidelines, Hospitality Business, Human Error, Improvement, Innovation, ISO,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by Thomas Agrait | Dec 13, 2018 | Audits, cGMP, Communication, Compliance, Draft Guidance, FDA Inspection, FDA New Guidelines, FDA News, Guidelines, Mitigation Strategies, Outsourcing, Process Improvement, Public Health, QA, Quality Systems, Training
Policies for Outsourcing Facilities Posted 10 December 2018 | By Ana Mulero The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance...
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