Quality Consulting Group

Services

We offer a wide range of services
specific to highly technical industries.

Planning & Assessment

  • GAP Analysis
  • Remediation Plans
  • Risk Management Assessments
  • Strategic Planning
  • Project Timelines Development
  • Project Management

Improvements

  • Lean Manufacturing Projects
  • Six Sigma Principles
  • Quality Risk Management Approach
  • Quality Systems
  • Manufacturing Processes

Implementation

  • Validations / Technology Transfer
  • Remediation Plans
  • Equipment Commissioning
  • Equipment Decommissioning
  • Equipment Qualification (IQ/OQ/PQ)and Automation

Sustainability Compliance

Analytical Laboratory Support

Specialized analysis of lab processes and results

  • Data Review
  • Laboratory Investigation
  • Environmental Monitoring Support

Manufacturing Support

Critical processes support for technical industries

  • Shop Floor Support
  • Startup Support
  • Documentation Review
  • Manufacturing Controls
  • Business & Quality Metrics Design and Monitoring

Documentation Management

  • Document Control
  • Lifecycle Documentation
  • Document Retention
  • Document Archiving
  • Control Security Documentation

 Training

  • On-Site and Off-Site Training
  • Technical Training
  • On the Job Training
  • Train the Trainers Certifications
  • New Hire Trainings

Engineering Control Support

  • Equipment Calibrations
  • Equipments Preventive Maintenance
  • Equipment Inventory
  • Equipment Qualification

Regulatory Affairs Support

  • NDA Documentation
  • NDA Filings & Post Approval Changes
  • PAI Readiness
  • CMC Sections

Quality Audit Management

  • Audit Preparation
  • Audit & GMP Inspections
  • Audit Response
  • Annual Product Reviews
  • Annual Product Reports

Quality Systems

  • APR’s
  • Change Controls
  • Investigations
  • Complaints
  • Out of Tolerance
  • SOP Revision
  • Quality Metrics Design and Monitoring

Validation

  • Re-validation
  • Re-qualification
  • Cleaning Validations
  • Process Improvements
  • Equipment Qualification

Components Specifications

For Products, Raw Materials and Packaging

  • Review, Management and Control

Environmental Health & Safety

  • OSHA
  • Disaster Recovery Plan
  • MSDS


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