BEQS - Consulting for Medical Device and Pharmaceutical Industry

Mock FDA Audit, Drug Manufacturing
Mock FDA Audit, SDLC, Blood
Mock FDA Audit, SDLC, Blood
Supplier Management System, Develop & Implement
CAPA System, Develop & Implement
Validation Review
Subcontractor Audit
Complaints Review & Remediation
Strategy
GMP Training
Mock FDA Audit, Consent Decree, Management Assessment
Complaint Review
Design Control System, Develop & Implement
Design Control & Process Validation, Review & Remediate
Quality System, Comprehensive Develop & Implement, Startup
Design Control Audit
Combination Product, Mock FDA Audit
Equipment & Process Validation Remediation, Drug
Quality System Remediation, Combination Device
Product Complaint Handling, Develop & Implement
Purchasing Control, Develop & Implement
Subcontractor Audit, Combination Device
Mock FDA Audit, Device
Quality System Remediation, Device
Design Control, SDLC, Device
Laboratory Controls, Drug
Quality System Remediation, Device
Subcontractor Audit
Subcontractor Audit
Quality System Remediation
Mock FDA Audit, Tobacco
Design Control, Develop & Implement
SDLC Audit , Clinical Trial
Mock FDA Audit, SDLC, Device, Biologics
Design Control, Audit, Remediation
Mock FDA Audit, Remediation Strategy, Device
Quality System Remediation, IVD
Deviation Review, Drug
Problem Solving, Device
Regulatory Review, Drug


	Quality System Remediation, IVD Conduct Audit of Quality System and develop Remediation Plan for In-vitro Diagnostic Devices.

Mr. Bacchus, currently of BEQS, was hired to initially conduct an audit of our CAPA system. During his audit we were duly impressed with his auditing techniques, but more importantly, he did a tremendous job during the audit of explaining the purpose of the QSR regulations versus the gaps in our Quality System. As a result, we retained Mr. Bacchus to conduct a complete audit of our Quality System and provide us with an FDA style 483 report, a gap analysis and corrective action recommendations. Mr. Bacchus was further retained to develop a strategy for correcting the systemic issues identified. He organized our company's resources into groups that focused on key elements of the quality system and with his direction, training and facilitation, we were able to reengineer our entire Quality System into one that is more effective. Mr. Bacchus' strengths include strategic thinking, training skills, understanding of how systems work and the ability to help us develop a simple and intuitive quality system solutions. It is with great pleasure that I recommend Mr. Bacchus of BEQS for his Quality System and Quality Engineering expertise.