Consulting Services with BioGlobaX

BioGlobaX creates and applies programs related to life sciences products and services. Our clients are local, provincial and international institutions in the private and public sectors. Our support is in the form of career advancement programs with available technologies. If the appropriate technologies are missing, research is the best option before the necessary changes can occur.

Career Advancement Programs

Our career advancement programs are designed to improve the effectiveness of the client’s organization by upgrading the professional skills of the staff. The training programs relate to instrument operations, analytical and bioanalytical techniques, and regulatory materials, using measurable performance objectives to improve knowledge levels and accountability. The programs enhance participant knowledge levels and their practical and problem-solving skills. Typical examples are programs related to instrument qualification.

Research Programs

Research programs prepare the client institution for designing and planning necessary improvements. Typical examples are programs related to preclinical drug discovery. We organize them according to QMS/QbD and Design of Experiments (DoE) principles, respectively. We work in partnership with professionals from universities, governments, and industries. Our local programs include collaborations with the University of Toronto, York University, and Ryerson University.

The QMS/QbD Related Programs

We work with our clients in a partnership environment where statistically-based scientifically sound principles of the QMS/QbD apply. This approach allows to minimize risk and cost and maximize the output for all parties, providing results that are consistent with regulatory expectations.

Building a successful business practice requires careful consideration of many aspects including the formation of quality circles and a quality council within the organization. Also, the development of a consortium with external stakeholders is a crucial point. Such structures provide an environment where it is possible to identify hidden issues. Then, solving problems and establishing a system for preventive action become a routine practice. These structures work together to promote the creation of policies that reflect the real state of affairs in a given organization: Where it is now and where it wants to be in the future.

Efficient communication between internal and external stakeholders is among the essential components. It allows the exchange of significant information such as defects coming from suppliers. Or, in-house error accumulation, due to a lack of technical knowledge, as many others.

To make the whole process most effective, statistics and appropriate presentation tools are essential. They help to screen the history of a process fast. Accordingly, identifying the causes of errors becomes a smooth operation. Also, presentations of trends and other interconnections between critical factors help to identify hidden needs and to expand the practice.

Innovations are an integral part of the best business enterprises. We support this initiative via continuous education and skills training. We create and deliver customized career advancement and research programs. Such kind of programs helps clients to improve the effectiveness of their organization. Our repository of educational and training materials consists of literature from pioneers of the QMS/QbD (see the references below), videos and our own program materials. We design them to serve as a continuing resource for our clients and partners.

If you are interested in adopting the QMS/QbD in your organization, a good starting point is to build a library with literature written by the best-known professionals who created the QMS/QbD philosophy. And also, please do not hesitate to contact us if you have any further questions.

Suggested Authors and Literature: