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.
There will be a $95 fee upon acceptance into the program