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Comment Showing 26 courses for regulatory affairs.

Course Quarter Units Fall Winter Spring Summer
Science of Clinical Trials Design 2.5 Summer TBD
Clinical Statistics for Non-Statisticians 2.0 Winter TBD
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 Fall TBD Spring TBD
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 Winter TBD
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 Fall TBD Spring TBD
Communicating and Negotiating with the FDA 1.5 Fall TBD Spring TBD
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 Spring TBD
Global Medical Device Submissions and Strategy 1.5
Regulatory Submissions: Devices and Diagnostics 2.5 Spring TBD
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance 3.0
Clinical Trials Essentials: An Intensive One-Week Course 3.5 Summer TBD