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, Combination Device Conduct Audit, Develop and Implement Remediation Plan for Combination Product Development for large fortune 100 drug manufacturer.

During the period of February 2003 through April 2004, Mr. Mr. Bacchus was selected by our fortune 100 multinational pharmaceutical firm to lead a team of outside consultants and internal management representatives in two key initiatives.

Inspectional preparedness for a medical device product and facility.
Quality systems re-design and implementation in a new, state-of-the art parenteral facility

The first initiative involved rapid development of a plan and then preparedness testing thorough series of mock FDA inspections. The plan, authored by Mr. Bacchus, involved comprehensive assessment of all qualification packages and key regulatory submission documents; training of site representatives; establishment of a Purchasing and Materials Management System; redesign of the site CAPA systems; and conduct mock inspections. The plan was executed on time and fully met the expectations of the company. Furthermore, the final mock inspection was conducted by an ex-FDA investigator who commented very favorably on the readiness of the site.

The second initiative was a result of positive feedback on the above medical device project. In a new state-of-the art parenteral plant, Mr. Bacchus was challenged to implement entire quality management systems that would meet the latest expectations FDA. The systems were to be put in place of existing practices within the site and, in several instances, serve as a roadmap for the corporation with respect to updating it's Global Quality Systems. Mr. Bacchus began the project by educated site senior management on the Quality Systems Approach to quality management and by gaining support for a sweeping, 6-month project plan designed to revive the quality culture and teach advanced principles of good quality systems design and execution. His approach involved shop-floor personnel in eight focus group teams that designed basic process flows, controls points, metrics, and procedures all according common requirements for consistency and speed. Along the way, the management team and the shop floor personnel were able to learn the fundamentals and take strong ownership of the processes they helped develop. Quality system element champions were identified who led the focus teams were coached by Mr. Bacchus on Quality Management Principles and leadership styles necessary for effective control of the systems. The project was completed on time and within budget. Many elements of the quality system design implemented at the site were also adopted by neighboring sites and at the Corporate level are a testimony to his expertise in the design and on-going execution of Quality Management Systems.

Mr. Bacchus is a talented facilitator with the ability to communicate and execute a thorough plan. His organizational skills, coupled with an approachable, personal style make him a outstanding leader of major compliance projects. As his primary customer contact at our company, I can strongly recommend him.