Courses



Comment Showing 22 courses for regulatory affairs.

Course Units Fall Winter Spring Summer
Clinical Trials Essentials: An Intensive One-Week Course 3.5
Data Privacy and Security for Healthcare and Biosciences 1.5
Design Control for Medical Devices 2.0 + +
European Medical Device Regulation: Clinical Evaluation and Post-Market Surveillance 3.0
Global Medical Device Submissions and Strategy 1.5
Good Clinical Practices 3.0
Good Manufacturing Practices 3.0
ICH Quality Guidelines: Intent and Overview 2.0
Interacting with the FDA 1.5
Post-Market Regulatory Obligations for Medical Devices 1.5
Preparing for FDA Inspections and Conducting Sponsor Audits 1.5
Principles of Drug Discovery and Development 4.0
Quality Systems for Medical Devices: FDA QSR and ISO 13485 2.5
Regulation of Drugs and Biologics 3.0
Regulation of Medical Devices and Diagnostics 3.0
Regulation of in vitro Diagnostics in Europe and the US 2.5
Regulatory Affairs Certificate Completion Fee None
Regulatory Submissions: Devices and Diagnostics 2.5
Regulatory Submissions: Drugs and Biologics 2.0
Risk Management for Regulated Industries 3.0
Validating Software for Medical Devices and Emerging Technologies 2.0
Value-Added Quality Audits 1.5