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
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
Staffing and Outsourcing
- Innovative and reliable staffing services
- Recruiting and outsourcing solutions for businesses
- Fast-paced hiring system
ABOUT US
At Quality Consulting Group LLC, we plan, implement and support effective and efficient business processes that assure sustainable compliance with highly technical regulatory standards.
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