Scopus Consulting, LLC

+1(732) 331-5404

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  • PRESIDENT, CEO & CHIEF CO
  • AREAS OF COLLABORATION
    • REGULATORY AFFAIRS
    • Quality Compliance System
    • VALIDATION STRATEGIES
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  • PARTIAL CLIENT LIST
  • NEWS & EVENTS
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  • More
    • HOME
    • ABOUT US
    • PRESIDENT, CEO & CHIEF CO
    • AREAS OF COLLABORATION
      • REGULATORY AFFAIRS
      • Quality Compliance System
      • VALIDATION STRATEGIES
    • ON-SITE TRAINING OFFERING
    • PARTIAL CLIENT LIST
    • NEWS & EVENTS
    • CAREERS
    • CONTACT US
Scopus Consulting, LLC

+1(732) 331-5404

  • HOME
  • ABOUT US
  • PRESIDENT, CEO & CHIEF CO
  • AREAS OF COLLABORATION
    • REGULATORY AFFAIRS
    • Quality Compliance System
    • VALIDATION STRATEGIES
  • ON-SITE TRAINING OFFERING
  • PARTIAL CLIENT LIST
  • NEWS & EVENTS
  • CAREERS
  • CONTACT US

Enhancing Potentials Through On-Site Training

Regulatory Affairs Seminars

Validation Strategies Seminars

Regulatory Affairs Seminars

  • SC-RA/50-001: [2 Days] Drug Establishment Application and Listing
  • SC-RA/50-002: [2 Days] Introduction to Clinical Trial Planning and Management
  • SC-RA/50-003: [2 Days] Planning the Clinical Trial
  • SC-RA/50-004: [2 Days] Managing the Site and Process of the Clinical Trial
  • SC-RA/50-005: [2 Days] Auditing Clinical Trial Master Files
  • SC-RA/50-006: [

  • SC-RA/50-001: [2 Days] Drug Establishment Application and Listing
  • SC-RA/50-002: [2 Days] Introduction to Clinical Trial Planning and Management
  • SC-RA/50-003: [2 Days] Planning the Clinical Trial
  • SC-RA/50-004: [2 Days] Managing the Site and Process of the Clinical Trial
  • SC-RA/50-005: [2 Days] Auditing Clinical Trial Master Files
  • SC-RA/50-006: [3 Days] Routine cGMP Audit
  • SC-RA/50-007: [3 Days] Due Diligence cGMP Audit
  • SC-RA/50-008: [3 Days] Mock PAI cGMP Inspection/Audit
  • SC-RA/50-009: [2 Days] Focused Audit for Good Laboratory Practices (GLPs)
  • SC-RA/50-010: [2 Days] Focused Audit for Good Clinical Practices (GCPs)
  • SC-RA/50-011: [2 Days] Focused Audit for Good Documentation Practices (GDPs)
  • SC-RA/50-012: [2 Days] Focused Audit for Good Automated Practices (GAPs)
  • SC-RA/50-013: [2 Days] Focused Audit for Application Data Integrity (ADI for AIP)
  • SC-RA/50-014: [2 Days] Fundamentals of Systems Based Audits and Inspections
  • SC-RA/50-015: [2 Days] The Effective Internal Audit Program
  • SC-RA/50-016: [2 Days] Interpreting Global Guidelines for cGMP Practices: WHO, ICH, FDA
  • SC-RA/50-017: [2 Days] A Comparative Analysis of Regional GMP Requirements: USA, EU, Japan, ROW (Rest of the World)
  • SC-RA/50-018: [3 Days] Guidelines for Effective cGMP Audits
  • SC-RA/50-019: [1 Day] Tracking Outcomes of cGMP Audits
  • SC-RA/50-020: [2 Days] Electronic Document Management and Electronic Signatures
  • SC-RA/50-021: [2 Days] Managing Regulatory Agency Inspections
  • SC-RA/50-022: [2 Days] Understanding ICH-CTD Requirements for Regulatory Agency Applications [e.g., Drug Master File (DMF) Dossiers, MAAs, NDAs, NDSs, BLAs, CTAs]
  • SC-RA/50-023: [2 Days] Steps Towards Assuring Regulatory Agency Approval of Submissions
  • SC-RA/50-024: [2 Days] Addressing Variations and Deficiency Letters Related to Regulatory Agency Applications [e.g., Drug Master File (DMF) Dossiers, MAAs, NDAs, NDSs, BLAs, CTAs]
  • SC-RA/50-025: [2 Days] Compiling Approvable CMC (Chemistry, Manufacturing, and Controls) Packages
  • SC-RA/50-026: [2 Days] Compliant Safety Considerations in Biologics and Biotechnology Manufacturing Operations
  • SC-RA/50-027: [2 Days] Case Studies in Global Regulatory Submissions

Quality Systems Seminars

Validation Strategies Seminars

Regulatory Affairs Seminars

  • SC-QS/60-001: [3 Days]: Key Elements of Supplier Quality Management
  • SC-QS/60-002: [2 Days] An Analysis of the Key Elements of the Cost of Quality
  • SC-QS/60-003: [2 Days] Employee Safety in the Workplace
  • SC-QS/60-004: [2 Days] Managing Product Recalls, Market Withdrawals, and Stock Recoveries
  • SC-QS/60-005: [3 Days] Evaluating Employee Performan

  • SC-QS/60-001: [3 Days]: Key Elements of Supplier Quality Management
  • SC-QS/60-002: [2 Days] An Analysis of the Key Elements of the Cost of Quality
  • SC-QS/60-003: [2 Days] Employee Safety in the Workplace
  • SC-QS/60-004: [2 Days] Managing Product Recalls, Market Withdrawals, and Stock Recoveries
  • SC-QS/60-005: [3 Days] Evaluating Employee Performance for Improved Productivity
  • SC-QS/60-006: [2 Days] Fundamentals of Statistical Process Control
  • SC-QS/60-007: [2 Days] Basic Principles of Design of Experiments (DoE)
  • SC-QS/60-008: [2 Days] Strategic Phases in Process Analytical Technology (PAT)
  • SC-QS/60-009: [2 Days] Introduction to Quality Function Deployment (QFD)
  • SC-QS/60-010: [2 Days] Understanding the Key Elements of “Quality by Design”
  • SC-QS/60-011: [2 Days] Guidelines for Compliant Sterile Operations
  • SC-QS/60-012: [2 Days] Understanding the ISO-9000 Quality Management System
  • SC-QS/60-013: [2 Days] A Practical Approach to the Implementation of the ISO-9001-2000 Quality Management System Standards
  • SC-QS/60-014: [2 Days] A Practical Approach to the Implementation of ISO-13485 - Quality Management System for Medical Devices
  • SC-QS/60-015: [2 Days] Understanding the ISO-14000 Environmental Management System
  • SC-QS/60-016: [2 Days] Overview of the ISO-14004 Guidance on the Structural Approach to ISO-14001, Environmental Management System Standards
  • SC-QS/60-017: [2 Days] A Practical Approach to the Implementation of the ISO-14001 Environmental Management System Standards
  • SC-QS/60-018: [2 Days] Understanding and Meeting Compliance Challenges of Transmissible Spongiform Encephalopathies (TSEs)
  • SC-QS/60-019: [2 Days] Case Studies in Quality Management
  • SC-QS/60-020: [2 Days] Case Studies in the Management of Process Challenges

Validation Strategies Seminars

Validation Strategies Seminars

Validation Strategies Seminars

  • SC-VS/70-001: [2 Days] Manufacturing Facility Validation
  • SC-VS/70-002: [2 Days] Validation of Facility and Equipment Cleaning Methods
  • SC-VS/70-003: [2 Days] Control of Air Handling and Water Systems
  • SC-VS/70-004: [2 Days] Process Equipment Validation
  • SC-VS/70-005: [2 Days] Strategic Techniques for Successful Process Validation
  • SC-VS/70-006: [2

  • SC-VS/70-001: [2 Days] Manufacturing Facility Validation
  • SC-VS/70-002: [2 Days] Validation of Facility and Equipment Cleaning Methods
  • SC-VS/70-003: [2 Days] Control of Air Handling and Water Systems
  • SC-VS/70-004: [2 Days] Process Equipment Validation
  • SC-VS/70-005: [2 Days] Strategic Techniques for Successful Process Validation
  • SC-VS/70-006: [2 Days] Safety Assurance in the Design, Installation, and Maintenance of Fluid Networks
  • SC-VS/70-007: [2 Days] Validation of Computer and Electronic Systems
  • SC-VS/70-008: [2 Days] Validation by Design for Enhanced Return on Investment

Scopus Consulting, LLC continues to leverage its significant global experience in Regulatory Affairs, Quality and Compliance Systems and Validation Strategies to the benefit of its corporate clients that operate within the regulated industry. Our Consultants have a strong track record of successfully installing, enhancing, and maintaining routine and complex systems, processes, and programs in Regulatory Affairs, Quality and Compliance Systems, and Validation Strategies. Pursuant to our defined goals, our Consultants work closely with assigned clients, and routinely interface with various regulatory authorities, to ensure the successful launch and maintenance of products by each client. By enabling our clients to wisely manage the fine but critical details of their projects, we play a major part in continuously raising the quality of their operations to new heights of excellence. We encourage you to make us your partner in a mutually rewarding relationship. ​Call Today: +1(732) 331-5404


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  • HOME
  • ABOUT US
  • PRESIDENT, CEO & CHIEF CO
  • REGULATORY AFFAIRS
  • Quality Compliance System
  • VALIDATION STRATEGIES
  • ON-SITE TRAINING OFFERING
  • PARTIAL CLIENT LIST
  • NEWS & EVENTS
  • CAREERS
  • CONTACT US

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