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About the Quality Assurance and Control Program

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.

Complete the application and pay application fee.UC San Diego Extension programs are designed to best serve college-prepared working professionals. Although programs are open to all adult learners, where program capacity is limited, applicants with this profile will receive preference for admission.

Contact
Department
Science & Technology
Phone
858-534-9353
Email
unexbio@ucsd.edu

Courses

Delivery Method
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  • Live Online
  • In-Person
  • Online
  • Hybrid

Introduction to GXPsBIOL-40353

Units: 3.00

$675

The pharmaceutical industry is tightly regulated, allowing the commercial sale of medicinal products only if regulatory requirements are met. This course emphasizes the US FDA GXPs that apply to manag...

Upcoming Start Dates:
Typically Offered:

Winter, Summer

Quality ComplianceBIOL-40354

Units: 3.00

TBD

This introductory course highlights the challenges facing QA/QC in today s pharmaceutical manufacturing and control environment. Instruction covers the importance and underlying principles of QA/QC an...

Upcoming Start Dates:
Typically Offered:

Winter

Validation and QualificationBIOL-40355

Units: 3.00

TBD

Learn the regulatory requirements and practice of validation, qualification, and calibration activities in the pharmaceutical sector. Instruction covers regulatory requirements, process validation, fa...

Upcoming Start Dates:
Typically Offered:

Spring

Audits and InspectionsBIOL-40356

Units: 0.00

TBD

GXP audits and inspections are conducted to identify non-compliances, but also regulatory weaknesses and the potential for non-compliance. This course introduces students to GXP audits and inspections...

Upcoming Start Dates:
Typically Offered:

Fall

Must choose 1

QC OperationsBIOL-40341

Units: 3.00

TBD

Upcoming Start Dates:
Typically Offered:

Spring

Quality AssuranceBIOL-40342

Units: 3.00

TBD

This course focuses on the systems and oversight role of quality assurance professionals in the pharmaceutical industry. Students will understand the components of Pharmaceutical Quality Management, r...

Upcoming Start Dates:
Typically Offered:

Spring

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This certificate requires an application before taking any courses. There will be a $0 fee to apply to this program. Students will also be required to pay a $95 certificate fee upon enrollment into the program after acceptance. View the complete Certificate Registration and Candidacy Guidelines.