Medical discovery and commercialization

Students learn the journey of safe and ethical medical device and drug development. You will identify the critical roles in the industry, best practices for product documentation and risk management. Learn industry requirements, federal regulations and audits and global standards. Network with people in the industry.

Regulatory Affairs certificate program objectives

• Provide regulatory submissions of drugs and biologics
• Differentiate the roles and responsibilities between quality assurance (QA) and quality control (QC)
• Understand and apply GXPS (Good Manufacturing Practices (GMPS)/Quality System Regulation) for drugs/biologics/medical devices.
• Apply risk management principles to products, processes and services within biomedical industries
• Set up and implement medical device verification and validation programs

Please review the course descriptions to ensure that you have taken necessary prerequisites or meet the requirements through job experience or previous education. Students with a basic understanding of the life sciences and strong written and oral communication skills will gain the most from this program.

Begin with Quality Systems for Medical Devices FDA QSR and ISO 13485 (formerly Medical Device Quality Systems) or Good Manufacturing Practices, followed by Drug Development Process or Regulation of Medical Devices and Diagnostics. After that, courses may be taken in any order provided the prerequisites are met.

Substitutions

You may take one elective outside the certificate curriculum, if you receive prior approval from the Academic Services Department.

Dual Certification & Shared Credit

Learn more for Less: You can complete two bioscience certificate programs at UCSC Extension simultaneously or in sequence with fewer units than if the programs were taken individually. Students pursing two certificates need to:

• Complete the total number of units indicated in the table below.
• Complete all required courses for both programs.
• Count each unit only once.
• Select some electives that are common to both programs.

To receive your certificate

Upon completion of the course sequence you may request your Regulatory Affairs Certificate Completion Review.

Also recommended:

Data Privacy and Security for Healthcare and Biosciences, 1.5 units

Clinical Trials Essentials: An Intensive One-Week Course, 3.5 units

Dual Certification & Shared Credit

Earn two bioscience certificates with fewer units by selecting shared electives. Any one course from the Biotechnology certificate program may be applied toward the elective unit requirement for any other biosciences certificate program.

Regulatory Affairs Certification

Helps prepare professionals with three to five years in the regulatory field for the Regulatory Affairs Certification (RAC) exam, the only post-academic professional credential for regulatory professionals in the healthcare product sector.