by Thomas Agrait | Dec 26, 2019 | 483, Abundant Life, Admiration, Attitude, Believes, Business Decision Making, Business Process Transformation, CAPA, cGMP, Cleaning Validation, Collaboration, Compliance, Computer System Validation, Connection, Cost Reduction, Creativity, Cultural Diversity, Curiosity, Cybersecurity, D-M-A-I-C-S, Diversity, Draft Guidance, Drug Evaluation, Drugs & Biologics, Education, Efficiency, EMEA, Energy, Engineering, Envision, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News, FDA/CDER, FIIILE, Foreign Manufacturers, Gap, Good Documentation Practices, Guidelines, Happy New Year, Improvement, Innovation, ISO 56000, Leadership, Lean Enterprise Consulting, LEC Universitas, Manufacturing, Manufacturing Engineering, Medical Devices, Mindfulness, NDA, Neuro-Linguistic Programming, NeuroGneering @ VORTEX, Personal Development & Improvement, Pharma, Process Improvement, Quality Engineering, Quality System Operations, Quality Systems, Regulatory, Supplier Quality Agreement, Supplier Quality Management, Team Work, Technology, Third Party Audits, TIER System, Warning Letter
...
by Thomas Agrait | Dec 10, 2019 | Actions, Artificial Intelligence - AI, Audits, Biotech, Business Decision Making, Business Process Transformation, CAPA, cGMP, Clinical Trials, Communication, Compliance, Computational Neuroscience, Cost Reduction, D-M-A-I-C-S, Deep Learning (DL), Draft Guidance, Drugs & Biologics, Efficiency, EMA, Emotional Intelligence, Energy, Engineering, Ethics, FDA, Guidelines, Improvement, Innovation, Medical Devices, Multiple Intelligences, NeuroGneering @ VORTEX, NeuroLeadership, Personal Development & Improvement, Pharma, Process Improvement, QA, Quality System Operations, Quality Systems, Raw Material Inspection / Testing, Regulatory, Risk Assessment, ROI, Safety, SMED, Strategic Planning, Strengths Psychology, Supplier Quality Management, Supply Chain, Team Work, Technology, Time Management, Training, VORTEX by LEC
Education is what remains after one has forgotten what one has learned in school. Albert Einstein I would like to schedule a time to talk to all of you interested in developing your team in areas that will improve your performance and the bottom line of your...
by Thomas Agrait | Nov 22, 2019 | ANDA, ANVISA, Audits, Business Decision Making, Business Process Transformation, CAPA, CDERSBIA, cGMP, Cultural Diversity, D-M-A-I-C-S, DMF, Draft Guidance, eCTD Format, Efficiency, EMA, Engineering, Ethics, FDA, FDA Inspection, FDA New Guidelines, Gap, Human Error, Improvement, Innovation, ISO, Latin America, Lean Enterprise Consulting, LEC Universitas, Manufacturing, Medical Devices, Mitigation Strategies, NDA, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Profitability, Quality System Operations, Quality Systems, Recalls, Regulatory, Risk Assessment, RobertoCorrea, Strategic Planning, Supplier Quality Management, Training, Warning Letter
Eng. Roberto Correa Lead Consultant, Global Regulatory Affairs and Quality Assurance Lean Enterprise Consulting Eng. Correa is a Florida, USA – based global consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and...
by Thomas Agrait | Nov 20, 2019 | ANDA, Business Process Transformation, CDERSBIA, cGMP, Commitment, Communication, Draft Guidance, eCTD Format, FDA, FDA New Guidelines, FDA News, FDA/CDER, Improvement, Innovation, Manufacturing, NDA, NeuroGneering @ VORTEX, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Regulatory
FDA announced today the availability of draft guidance for industry entitled “Transdermal and Topical Delivery Systems – Product Development and Quality Considerations.” This guidance provides recommendations to applicants and manufacturers of transdermal...
by Thomas Agrait | Nov 18, 2019 | Business Process Transformation, Business Transformation, cGMP, Collaboration, Commitment, Communication, Community Involvement, Compliance, Draft Guidance, Efficiency, Envision, FDA, FDA Inspection, FDA News, Guidelines, Laws, Leadership, Lean Enterprise Consulting, LEC Universitas, Manufacturing, Mother Nature, Outsourcing, Personal Development & Improvement, Pharma, Professional Development, Public Health, Public Safety, Quality Systems, Raw Material Inspection / Testing, Regulatory, Risk Assessment, Safety, Supplements, Supply Chain
On Thursday, December 12, the South Florida Manufacturers Association and it’s Regulatory Affairs and Quality Committee will be hosting its first seminar titled: To Be or Not to Be Regulated? The Food and Drug Administration (FDA) regulates both finished dietary...
by Thomas Agrait | Nov 13, 2019 | Business Decision Making, Business Process Transformation, Draft Guidance, FDA New Guidelines, FDA News, Guidelines, Leadership, Legal, Logistics, Medical Devices, Process Improvement, Regulatory, Supply Chain
Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices to explain why the FDA may deny issuing a Certificate to Foreign Government (CFG)...
Recent Comments