Program Overview

Regulatory Affairs Essentials Certificate Program

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.

Program Overview

The Regulatory Affairs Essentials certificate 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.

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

To enroll in the certificate program, complete the application and, upon acceptance into the program, pay the $60 certificate fee. Although programs are open to all adult learners, UC San Diego Extended Studies programs are designed to best serve college-prepared working professionals. 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.

Program Details

• Duration: 9 -15 Months
• Tuition Fee: $3,580 (not including textbooks)

Key Program Topics

• Regulatory requirements and guidelines 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

Required Courses

Regulatory Requirements for Drugs & Biologics

• Units: 2.50
• Fee: $675.00
• Description: Discover the FDA regulatory requirements as they pertain to biotech and pharmaceutical companies.

Regulatory Compliance for Drugs & Biologics

• Units: 2.00
• Fee: $645.00
• Description: Learn the practical applications for ensuring regulatory compliance as required by FDA regulations for biologics and drug development.

Good Manufacturing Practices

• Units: 3.00
• Fee: $745.00
• Description: 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.

Good Laboratory Practices

• Units: 2.00
• Fee: $645.00
• Description: Address fundamental regulatory compliance principles relative to the FDA's current Good Laboratory Practice regulations.

Good Documentation Practices

• Units: 3.00
• Fee: $745.00
• Description: Cover fundamental principles and techniques required to write cGMP procedures, focusing on good documentation practices as a vital tool for assuring product quality, integrity, and consistency.