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Consulting in Quality Assurance and Regulatory Affairs does not always have to be about more complexity, paperwork and hinderances. We can help you unleash the power in your Quality System, reducing complaints, implement corrective and preventive action etc. all this while improving the speed at which your operation functions and reducing cost.
For specific feedback, refer to our recent project list for customer comments on our services provided.
Sample historical comments include:
During the period of February 2003 through April 2004, 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.
The first initiative involved rapid development of a plan and then preparedness testing thorough series of mock FDA inspections. The plan 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.
- 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 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 its Global Quality Systems. Mr. Bacchus began the project by educating 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, currently of BEQS, 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 an outstanding leader of major compliance projects. As his primary customer contact at our company, I can strongly recommend him.
During my time as the Sr. Director in charge of Quality System Management for Information Systems at our National Headquarters, Mr. Bacchus conducted a quality system audit of our department. This was at a very busy, tense and political time for our organization in the area of compliance. Paul was part of a team, with his specific role being the Information Systems department. I found Paul to be very knowledgeable of FDA regulations, quality standards, and industry practices. He understood not just the words of the regulations, but also the quality reasons and goals behind them. During the audit, Paul was respectful of staff and exhibited patience, making the audit experience also an education experience for all staff members who interacted with him. His diplomacy ultimately gained him more information, and therefore gained our organization a more useful audit. Paul is also very organized, methodical and thorough. If I challenged his understanding of a regulation, he was respectful of that challenge and would do the homework required to support his understanding. I recommend Paul Bacchus, currently of BEQS for his knowledge and approach to his work, and would hire his services again if the occasion arose.
Medical Device Client
Paul 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 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.