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Regulatory Affairs Essentials

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About the Regulatory Affairs Essentials Program

Regulatory Affairs is an excellent career for professionals who wish to work in a challenging and dynamic field that is at the center of science, business, government and most importantly, saving people’s lives.

The program provides professionals with a comprehensive and balanced education focusing on the key areas of regulatory affairs and the FDA imposed regulations pertinent to the pharmaceutical and biologics industry. This certificate covers a broad range of necessary technical and business skills, including GMP, GLP and data integrity. It is designed for professionals who want to participate in the process of drug development as regulatory professionals as well as provide a basic understanding to other experts involved directly in drug development process, including chemists, pharmacologists, and biologists.

  • Regulatory requirements and guidlines for the industry by FDA
  • Document Management Systems
  • Current trends in drug safety in the USA and the importance of Good Laboratory Practices regulations  
  • Application of guidance documents (ICH and FDA) to Good Manufacturing Practices
  • Develop a basic Quality Management System to manage GMPs
  • Implementation of data integrity standards
  • Writing SOPs
Format: Online

Estimated Cost: $3,345

not including textbooks

Duration: 9 -15 Months

Varies by student and courses taken per quarter.

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

Courses

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

Regulatory Compliance for Drugs & BiologicsBIOL-40101

Units: 2.00

$595

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

$625

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

$675

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

$595

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

$675

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.