Free Regulatory Affairs Course
Regulatory Affairs and Compliance
Regulatory affairs training shows why products need evidence before approval and safety checks afterward. Join this free course to compare drug and device pathways and understand how quality records support regulatory decisions.
About this course
Free regulatory affairs training connects product evidence to decisions made before and after a drug or device enters a market. Your course begins with the roles of authorities and the differences between approval pathways. You examine drug development alongside risk-based device classification, so you can understand why product type changes the information a submission needs. No previous regulatory study is assumed.
Quality systems and regulatory submission lessons then show how controlled records, labeling, and technical documents support a review. After approval, you study safety reporting, complaints, recalls, and change control to understand why compliance continues throughout the product lifecycle. Examples introduce strategy and inspection preparation without promising an approval outcome. You gain a foundation for further drug and device compliance study; current requirements and professional review remain necessary for real submissions.
Course outline
Understanding the Global Regulatory Landscape
In this module, you'll learn how ICH harmonises trial standards, how IRBs and ethics committees work, trial registration, GCP versus GLP and GMP, and inspection powers.
Navigating Drug Approval Pathways
In this module, you will learn about phases of clinical trials, IND/NDA basics, generics, biologics, orphan drugs and expedited approval pathways, combination products, and regional differences using case study.
Classifying and Registering Medical Devices
In this module, you will learn about risk-based classification of medical devices, 510(k)/PMA pathways, CE marking, IVDR, software as a medical device, labeling and UDI, technical documentation, and harmonization.
Building Compliant Quality Systems
In this module, you will learn about GMP, GCP, GLP, Quality Management Systems (QMS), ISO 13485/9001 standards, design controls, ISO 14971 risk management system, supplier management, and quality culture.
Preparing Compliant Regulatory Submissions
In this module, you will learn about submission requirements, CTD/eCTD format, document compliance writing, labeling, technical file preparation, timing, communication with the agencies, AI technologies, and version control.
Managing Product Safety After Approval
You will be taught about pharmacovigilance, adverse events, PSURs, signal detection, device surveillance and complaints, recalls, REMS, post-approval changes, and global vigilance databases within this module.
Driving Regulatory Strategy and Compliance
You will be taught about regulatory strategy, inspection preparation, audits and warning letters, CAPA, change control, multi-market compliance, agency relations, crisis management, artificial intelligence, and collaboration within this module.
Preparing for the Future of Regulatory Affairs
You will be taught about digital health, real world evidence, personalized medicine, decentralized trials, cell and gene therapy, sustainability, regulatory convergence, agile frameworks, and career development within this module.
Get access to the complete curriculum once you enroll in the course
Frequently Asked Questions
What regulatory authorities are introduced in this free course?
How does the course compare drug and device pathways?
Will I learn about clinical development and drug submissions?
What device documentation topics are included?
Does regulatory affairs training cover quality systems?
How are regulatory submissions and version control taught?
Will I study product safety after approval?
What will I learn about change control and corrective actions?
Can beginners take Regulatory Affairs and Compliance?
Does the course qualify me to submit a regulatory application?
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