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Connection, Cost Reduction, Creativity, Cultural Diversity, Curiosity, Cybersecurity, D-M-A-I-C-S, Diversity, Draft Guidance, Drug Evaluation, Drugs & Biologics, Education, Efficiency, EMEA, Energy, Engineering, Envision, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News,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 | Nov 26, 2019 | Adulterated Drugs, Business Process Transformation, CDERSBIA, cGMP, Compliance, FDA, FDA Inspection, FDA New Guidelines, FDA News, FDA/CDER, Foreign Manufacturers, Lean Enterprise Consulting, Legal, Networking Event, Pharma, Professional Development, ProfessionalAssociation, Quality System Operations, Quality Systems, Raw Material Inspection / Testing, Regulatory, Risk Assessment, RobertoCorrea, Training
...
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Business Decision Making, Business Process Transformation, CAPA, CDERSBIA, cGMP, Cultural Diversity, D-M-A-I-C-S, DMF, Draft Guidance, eCTD Format, Efficiency, EMA, Engineering, Ethics, FDA, FDA Inspection, FDA New Guidelines, Gap, Human Error, Improvement, Innovation, ISO, Latin America,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 21, 2019 | Business Decision Making, Business Process Transformation, Business Transformation, cGMP, Citizenship, Collaboration, Commitment, Communication, Community Involvement, Compliance, Connection, Creativity, Draft Guidamce, Efficiency, Engagement, Engineering, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News, Improvement, Innovation, Manufacturing, Motivation, Networking Event, Pharma, Process Improvement, Professional Development, ProfessionalAssociation, Public Health, Public Safety, QA, Quality Systems, Recalls, Regulatory, Respect, Risk Assessment, Supplements, Warning Letter
You and your team are invited on Thursday, December 12, the SFMA’s Regulatory Affairs and Quality Committee will be hosting its first seminar titled: To Be or Not to Be? (Register now) Looking forward to seeing you there to share our knowledge and regulatory concerns...
by Thomas Agrait | Nov 19, 2019 | Audits, Biotech, Business Process Transformation, CAPA, cGMP, Collaboration, Commitment, Communication, Compliance, D-M-A-I-C-S, FDA Inspection, Improvement, Innovation, Job Opportunities, Manufacturing, Medical Devices, Personal Development & Improvement, Pharma, Process Improvement, Professional Development, Puerto Rico, QA, Quality Systems, Recruiting, Regulatory, Sensitivity, Strengths Psychology, Team Work, Work-Life Balance
Lean Enterprise Consulting, Assisting Companies to Unleash Human...
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...
Recent Comments