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Quality and Compliance Accelerator Program
We understand that while quality and complaince are paramount. Organizations may not always have the resources or expertise to meet the demands of a growing organization and the expectations of the US FDA and global health authorities. Let us help you meet your quality goals and objectives with the cost and flexibility you need.
Compliance Basics
$
2800 and up
Monthly
- Up to 10 Hours Per Month
- Quality Management System (QMS) Design Review
- Quality Management System (QMS) Design Redesign
- Training and Qualification Process Review
- Virtual New Hire GxP Training
- On-Demand GxP Training
- Inspection Readiness Training
- QMS Review (Deviations, CAPA, Change Control)
- Document Management Review (Impact and Periodic Reviews)
- Quality Operations Support
- Regulatory Support
- 21 CFR Part 11 Assessment
- Equipment Qualification
- Computer Systems Validation
- Paper-Based QMS Implementation
- SOP Writing
- Conversion to Paper-less QMS
- Process Consulting
- Supplier Qualification
- Internal Audits
- GxP Technology Consulting
- GxP Technology Implementation
- Project Management
- GxP Assessments
- GxP Strategy
- Additional hours are available at a discounted rate
;
Compliance Assurance
$
5000 and up
Monthly
- Up to 20 Hours Per Month
- Quality Management System (QMS) Design Review
- Quality Management System (QMS) Design Redesign
- Training and Qualification Process Review
- Virtual New Hire GxP Training
- On-Demand GxP Training
- Inspection Readiness Training
- QMS Review (Deviations, CAPA, Change Control)
- Document Management Review (Impact and Periodic Reviews)
- Quality Operations Support
- Regulatory Support
- 21 CFR Part 11 Assessment
- Equipment Qualification
- Computer Systems Validation
- Paper-Based QMS Implementation
- SOP Writing
- Conversion to Paper-less QMS
- Process Consulting
- Supplier Qualification
- Internal Audits
- GxP Technology Consulting
- GxP Technology Implementation
- Project Management
- GxP Assessments
- GxP Strategy
- Additional hours are available at a discounted rate
;
Compliance Transformation
$
9000 and up
Monthly
- Up to 40 Hours Per Month
- Quality Management System (QMS) Design Review
- Quality Management System (QMS) Design Redesign
- Training and Qualification Process Review
- Virtual New Hire GxP Training
- On-Demand GxP Training
- Inspection Readiness Training
- QMS Review (Deviations, CAPA, Change Control)
- Document Management Review (Impact and Periodic Reviews)
- Quality Operations Support
- Regulatory Support
- 21 CFR Part 11 Assessment
- Equipment Qualification
- Computer Systems Validation
- Paper-Based QMS Implementation
- SOP Writing
- Conversion to Paper-less QMS
- Process Consulting
- Supplier Qualification
- Internal Audits
- GxP Technology Consulting
- GxP Technology Implementation
- Project Management
- GxP Assessments
- GxP Strategy
- Additional hours are available at a discounted rate
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