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Courses


Certificate courses open for enrollment



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Comment Showing 23 courses for regulatory affairs.

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

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