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Connection, Cost Reduction, Creativity, Cultural Diversity, Curiosity, Cybersecurity, D-M-A-I-C-S, Diversity, Draft Guidance, Drug Evaluation, Drugs & Biologics, Education, Efficiency, EMEA, Energy, Engineering, Envision, Ethics, FDA, FDA Inspection, FDA New Guidelines, FDA News,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
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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
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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Business Decision Making, Business Process Transformation, CAPA, CDERSBIA, cGMP, Cultural Diversity, D-M-A-I-C-S, DMF, Draft Guidance, eCTD Format, Efficiency, EMA, Engineering, Ethics, FDA, FDA Inspection, FDA New Guidelines, Gap, Human Error, Improvement, Innovation, ISO, Latin America,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 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 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)...
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