Courses

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Showing 26 courses for regulatory affairs.

Course	Quarter Units	Fall	Winter	Spring	Summer
Science of Clinical Trials Design	2.5
Clinical Statistics for Non-Statisticians	2.0
Regulation of in vitro Diagnostics in Europe and the US	2.5
Good Manufacturing Practices	3.0
Validating Software for Medical Devices and Emerging Technologies	2.0
Risk Management for Regulated Industries	3.0
Post-Market Regulatory Obligations for Medical Devices	1.5
Mobile Health, SaMD, and AI/ML Devices	1.0
Medical Device Process Validation	2.0
Value-Added Quality Audits	1.5
Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment	2.0
Immunology, Principles	3.0
Gene Therapy: Hacking the Genome	1.5
Principles of Drug Discovery and Development	4.0
Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements	3.0
Good Clinical Practices	3.0
Design Control for Medical Devices	2.0
Drug Safety and Adverse Events Reporting	1.5
Communicating and Negotiating with the FDA	1.5
Preparing for FDA Inspections and Conducting Sponsor Audits	1.5
Data Privacy and Security for Healthcare and Biosciences	1.5
Document Preparation: Protocols, Reports, Summaries	1.5
Global Medical Device Submissions and Strategy	1.5
Regulatory Submissions: Devices and Diagnostics	2.5
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance	3.0
Clinical Trials Essentials: An Intensive One-Week Course	3.5