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


	Problem Solving, Device Facilitate Problem Solving to investigate and resolve top ten complaints for respiratory devices for large European Medical Device manufacturer.

Mr. Bacchus provided excellent facilitation of ten teams organized to investigate our top ten complaints. As a result there were complete CAPA files prepared and both corrective and preventive solutions were identified and implementation initiated. Mr. Bacchus possesses excellent knowledge of the Quality System Regulations and Quality Engineering skills.