Coronavirus (COVID-19) Update

Enjoy a fully remote summer of professional education at the Silicon Valley Campus and the re-emergence of in-person courses in September. Visit our COVID update page.

Courses


Certificate courses open for enrollment



Upskill in 30 Days or Less

Comment Showing 23 courses for regulatory affairs.

Course Units Fall Winter Spring Summer
Principles of Drug Discovery and Development 4.0
Quality Management Systems for Medical Devices: ISO 13485 and FDA Requirements 2.5
Design Control for Medical Devices 2.0
Good Clinical Practices 3.0
Drug Safety and Adverse Events Reporting 1.5
Communicating and Negotiating with the FDA 1.5
Risk Management for Regulated Industries 3.0
Validating Software for Medical Devices and Emerging Technologies 2.0
Data Privacy and Security for Healthcare and Biosciences 1.5
Regulatory Submissions: Devices and Diagnostics 2.5
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5
Good Manufacturing Practices 3.0
Regulation of Medical Devices and Diagnostics 3.0 Winter TBD
Regulation of Drugs and Biologics 3.0
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance 3.0
Post-Market Regulatory Obligations for Medical Devices 1.5
Global Medical Device Submissions and Strategy 1.5
Regulation of in vitro Diagnostics in Europe and the US 2.5
Foundations in U.S. FDA Regulations of Drugs & Biologics and Regulatory Submissions 2.0
Foundations in Medical Devices: Developing Premarket U.S. Regulatory Strategies and Working in a Regulated Environment 2.0
Regulation of Drugs & Biologics: Strategic Biopharmaceutical Product Development 3.0
Value-Added Quality Audits 1.5
Clinical Trials Essentials: An Intensive One-Week Course 3.5

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Upskill in 30 Days or Less