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, Device Design & Implement Document & Records Control System. Audit Software Development process. Conduct Training on New Document & Records Control system at worldwide sites (Diabetes related Device) for large fortune 500 device manufacturer.

Mr. Bacchus was part of a large team of ex-FDA and industry consultants hired by our firm to conduct audits and remediate our Quality System. Mr. Bacchus was assigned the task of facilitating a team, using six sigma techniques, to remediate the firms Document & Records Control system, as well as Software Quality Assurance practices. Mr. Bacchus did an excellent job facilitating the team to develop a state-of-the-art process, along with a cutting edge approval process, developed using algorithms from DOE matrices. Mr. Bacchus is an exceptional consultant with superb Quality System expertise, communication and training skills.