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Regulatory Affairs Essentials

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About the Regulatory Affairs Essentials Program

Courses

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

Regulatory Compliance for Drugs & BiologicsBIOL-40101

Units: 2.00

$595-$675

Regulatory Compliance is the level of activity that provides assurance to the sponsor and the regulatory agency that all phases of drug development are conducted in compliance to the good practice reg...

Upcoming Start Dates:
Typically Offered: Fall, Winter, Spring, Summer

Regulatory Requirements for Drugs & BiologicsBIOL-40102

Units: 2.50

$675

Discover the FDA regulatory requirements as they pertain to biotech and pharmaceutical companies. In this course, you will review topics such as: FDA organization and operations; U.S. Pharmacopoeial c...

Upcoming Start Dates:
Typically Offered: Fall, Winter, Spring, Summer

Good Manufacturing PracticesBIOL-40000

Units: 3.00

$725

Gain a comprehensive understanding in FDA compliance with current good manufacturing practices (cGMPs), as regulated and guided by national and international agencies for the pharmaceutical and indust...

Upcoming Start Dates:
Typically Offered: Fall, Winter, Spring, Summer

Good Laboratory PracticesBIOL-40085

Units: 2.00

$645

By addressing fundamental regulatory compliance principles relative to the FDA's current Good Laboratory Practice regulations, this course will show how GLP's affect the conduct of non-clinical labora...

Upcoming Start Dates:
Typically Offered: Winter, Summer

Good Documentation PracticesBIOL-40201

Units: 3.00

$725

The most vital tool available for assuring product quality, integrity, and consistency is good documentation practices. This highly interactive course covers fundamental principles and techniques requ...

Upcoming Start Dates:
Typically Offered: Fall, Spring
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Conditions for Admission

To enroll in the certificate program, complete the application and, upon acceptance into the program, pay the certificate 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.

Certificate Guidelines

There are five required courses in the Regulatory Affairs Essentials certificate. Students may take courses in any sequence, although taking “Regulatory Requirements for Drugs and Biologics” first is highly recommended.

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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.