by Thomas Agrait | Jun 6, 2018 | Audits, CAPA, Communication, Compliance, Engineering, FDA Inspection, Guidelines, Human Error, Innovation, ISO, Logistics, Manufacturing, Medical Devices, Mitigation Strategies, Quality Systems, Recruiting, Regulatory, Risk Assessment, Training
Meet Yvette @ Lean Enterprise Consulting Inc. Professional Summary: Dedicated professional, eager to provide services in general Quality Systems, using knowledge acquired during 25 years of service to regulated environments: Pharmaceuticals, Medical Devices,...
by Thomas Agrait | Jun 6, 2018 | Commitment, Communication, Compliance, Engineering, Envision, Ethics, FDA, Guidelines, Innovation, Manufacturing, Medical Devices, Process Improvement, Recognition, Regulatory, Risk Assessment, Team Work, Technology
Please join our client, OSCOR, at the 2nd Intervention Congress of the DGA in Hamburg and learn about their new introducers and steerable guide sheaths – “The Destino Twist and Destino Reach”. The Destino Twist and Destino Reach are the ideal...
by Thomas Agrait | Jun 1, 2018 | Communication, Compliance, Engineering, FDA, Guidelines, Innovation, Laws, Medical Devices, Regulatory
FDA Announces Certain Class II Devices Exempt from Premarket Notification Requirements Today’s Federal Register announces the FDA’s exemption of a list of certain class II devices from premarket notification [510(k)] requirements. This finalizes the proposed list of...
by Thomas Agrait | May 31, 2018 | Communication, Compliance, Engineering, FDA, Guidelines, Laws, Manufacturing, Medical Devices, Mitigation Strategies, Pharma, Professional Development, Regulatory, Risk Assessment, Training
The U.S. Food and Drug Administration (FDA) issued two guidances today related to shared system risk evaluation and mitigation strategies (REMS). A REMS is a required risk management plan that uses tools beyond the approved labeling (prescribing information) to manage...
by Thomas Agrait | May 10, 2018 | Commitment, Communication, Compliance, Computational Neuroscience, Deep Learning (DL), Energy, Engineering, Envision, Ethics, FDA, Innovation, Laws, Leadership, Regulatory, Team Work, Tech, Technology, Training
What is Lean Enterprise Consulting and how this team of SMEs can assist you ? Lean Enterprise Consulting Inc. (LEC) is a leading provider of business improvement solutions utilizing actual science-based management methodologies. Comprised of management interventions,...
by Thomas Agrait | May 3, 2018 | Biotech, Communication, Community Service, Compliance, Engineering, Environmental Responsibility, FDA, Guidelines, Innovation, Manufacturing, Medical Devices, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Regulatory, Technology, Training
ASQ section 1510/1515 Joint Dinner Meeting: May 15, 2018 And Lean Enterprise Consulting Inc. Invites you to join us REGISTER HERE Speaker Eng. Julio Juarbe,S.M.E. Presentation Topic Filtration – Protecting What Matters most Every Day! at Shula’s Hotel, 15255 Bull...
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