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OPTI Medical Systems supports the Online Quality Assurance Program (QAP) to add value to your OPTI CCA-TS2 analyzer. Online QAP facilitates the evaluation of quality control (QC) data with that of your peers for trends and shifts. Do not miss out on these valuable services that OPTI Medical provides OPTI analyzer users at no additional charge.

The Graduate Certificate in Quality Assurance Compliance provides an in-depth knowledge of the global regulatory and compliance requirements for the development, marketing approval, and clinical utilization of biomedical products in today’s dynamic global healthcare environment.

This program is designed for the chemist, bio-chemist or biologist in the pharmaceutical and biologic industry new to quality assurance and control, and is beneficial to senior year undergraduates and graduate students (using concurrent enrollment) interested in a career in QA/QC.

The program focuses on the quality requirements for the production and control of biologics and drugs, and the differences between quality control and quality assurance and their interaction with manufacturing. It highlights the importance of implementing and maintaining a quality system during the early stages of drug development, including the plethora of documents and controls necessary to make such a system effective. Guidelines and regulations from the FDA and the California State food and drug branch regulate the production of drug products. Quality Assurance (QA) monitors the manufacturer's compliance to these guidelines and regulations.

Instruction covers how to write, issue and control SOPs; manufacturing directions; and how to review and archive a batch history and other relevant documents. Emphasis is placed on conducting inspections and vendor audits for compliance to cGMPs to include contract manufacturers, bulk pharmaceutical chemical manufacturers and contract test laboratories. The program covers cGLPs and their applications to audits of facilities that provide toxicological services. Details on compiling, writing and archiving audit reports is provided.

Quality assurance training helps applicants for understanding the basic concepts of information technology and software testing which help them excel as Quality Assurance (QA) specialists. The quality assurance course also covers physical products in determining defects in manufactured products and preventing them, pre-production, SDLC-Software Development Life Cycle, Production Environment vs Sandbox Environment, Mantis Bug Tracker, and many more. During the QA online training, you will learn how to decode the application of dynamic and static techniques, conduct walk-thoughts and audits, create a quality analysis, perform boundary value analysis, and test plan hands-on through this Quality assurance certification training.

Mount St. Mary’s University is home to Maryland’s only certificate in quality assurance and regulatory science (QA/RS). The fully online program prepares you to lead your company through the efficient delivery of high-quality products within a competitive market.