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
- 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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QUALITY OPERATIONS SERVICES
Risk Assessment, APR’s, Change Controls, Investigations, Product Quality complaints, Project Management and more.
VALIDATION SERVICES
Technology Transfers, Manufacturing Controls, Process and Cleaning Validations, Equipment Qualifications (IQ/OQ/PQ).
REGULATORY COMPLIANCE
NDA documentation, Filings and Post Approval Changes. PAI Readiness, Audit Management and Audit Response & Monitoring.
FACILITIES / UTILITIES
Environmental Health & Safety, Water Systems, Corrective and Preventive Maintenance Support, Equipment Inventory are some of the Facilities and Utilities services we offer.
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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