UC San Diego Extension Certificate Programs
Banner
Various Ads

Quality Assurance and Control Certificate

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.

Email Newsletters

Receive emails about upcoming Life Sciences events and courses.

Manage your email subscriptions via My Extension.

Tools

Email Icon Email This Page

Print Icon Print This Page

Request Information Icon Request Information

Share Icon Share

Certificate Course Matrix
Course Title Course Number Units FA WI SP SU
Required Courses
Introduction to QA/QC for Drugs & Biologics
BIOL-40038
3
  O   O
Advanced QA/QC for Drugs & Biologics
BIOL-40021
3
O   O  
Good Manufacturing Practices
BIOL-40000
3
  O   O
Regulatory Compliance for Drugs & Biologics
BIOL-40101
2
O O O O
L=La Jolla M=Mission Valley O=Online U=University City X=Location TBA
Certificate Programs

To Register in the Certificate Program

Certificate registration is required to complete the program. Candidates are encouraged to register in the certificate program as early as possible to take advantage of program benefits. See Certificate FAQs for more information.

Certificate Section ID: 100616 Add to Cart
Application Fee: $60
Contact: Life Sciences, (858) 534-9353
E-mail: unexbio3@ucsd.edu