Certificate

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 Regulatory Affairs Essentials certificate 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. The certificate covers a broad range of necessary technical and business skills. It is designed to provide a basic preparation to professionals who want to participate in the process of drug development as regulatory and quality assurance and control professionals as well as provide a basic understanding to other experts involved directly in drug development process, including chemists, pharmacologists, and biologists.

The Regulatory Affairs Essentials certificate, which grew from demands by the industry, offers a well-rounded curriculum and provides career growth and opportunities for students interested in the Regulatory Affairs industry. The program will enable students to transition into the life science industry and launch careers as regulatory and compliance professionals.

Certificate Benefits

Learn the practical applications for ensuring regulatory compliance as required by the FDA regulations for Biologics and Drug development.

Explore Good Documentation Practices for companies performing activities regulated by the FDA

Understand the current trends in drug safety in the USA and the importance of GLP regulations

Complete the certificate entirely ONLINE

Develop the knowledge needed to enter the Advanced Studies for Regulatory Science certificate

Conditions for Admission

Certificate Guidelines

Online

9 -15 Months

Varies by student and courses taken per quarter.

$3,345

not including textbooks

Key Program Topics

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

For detailed information, please contact our Science & Technology department.

Regulatory Affairs Essentials

Required Courses

Regulatory Requirements for Drugs & Biologics

BIOL-40102

Units: 2.50

$675.00

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 convention; INDs; the product development process; product characterization and pre-clinical evaluation; pharmacology/toxicology for new drugs and GLPs; clinical investigations, bioresearch monitoring and GCPs; and CMC requirements and GMPs. Also covered are the roles that regulatory affairs professionals play in the process.

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Regulatory Compliance for Drugs & Biologics

BIOL-40101

Units: 2.00

TBD

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 regulations as mandated by the Federal Food, Drug, and Cosmetic (FD&C) Act. In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development. You will also examine how a pharmaceutical or biotechnology company can use the graded approach when following the good manufacturing practice (GMP) regulations for...

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Good Manufacturing Practices

BIOL-40000

Units: 3.00

$745.00

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 industry. The course will emphasize the US FDA cGMPs and briefly touch on differences between the other regional markets in the rest of the world. In addition to pharmaceutical applications, nutritional supplements will also be discussed since this industry is held to standards very similar to therapeutics. The goal of this course is to teach you how to apply the knowledge gained about GMP...

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Good Laboratory Practices

BIOL-40085

Units: 2.00

$645.00

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 laboratory research, QA audit programs and FDA inspections. You will gain an in-depth understanding of specific critical GLP requirements such as the role of the QAU, study director, test and control articles. Preparation for FDA GLP inspections and current inspection trends, basic elements of GLP documentation, and considerations for lab facilities, equipment, and animals are covered.

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Good Documentation Practices

BIOL-40201

Units: 3.00

TBD

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 required to write cGMP procedures. Students can bring samples of their own documentation to be audited during the course. Students will learn techniques to write and improve cGMP documentation to ensure compliance with regulatory documentation. Topics Include: Document Hierarchy, Document Pyramid SOPs Document Control Laboratory notebook Con Data Integrity and GXP Compliance Auditing Practical...

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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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Regulatory Affairs Essentials

About the Regulatory Affairs Essentials Program

Key Program Topics

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