Course Catalog

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RAPS course bundles consist of relational topics that intersect in practice. Bundles offer a quick and cost-effective option to build expertise in a defined area.

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Product BundleProduct Bundle
Clinical Trial Foundations Bundle
Member: $575.00 Nonmember: $790.00
Improve your knowledge surrounding the proper conduct of clinical research with human subjects.
Product BundleProduct Bundle
GxP Bundle
Member: $865.00 Nonmember: $1,292.00
This three-course series examines essential topics within a quality system—Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
Product BundleProduct Bundle
Regulatory Basics Bundle - Complete
Member: $500.00 Nonmember: $700.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Product BundleProduct Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Product BundleProduct Bundle
Regulatory Medical Writing Bundle [Complete Package]
Member: $1,240.00 Nonmember: $1,710.00
Learn more about the components of various application types and techniques for improving document quality.
Product BundleProduct Bundle
Regulatory Medical Writing Bundle [Package #1]
Member: $1,050.00 Nonmember: $1,440.00
Learn more about the components of various application types and techniques for improving document quality.

The Regulatory Affairs Certificate Program is an online series of courses you personalize to meet your professional development needs. These customizable study pathways include four core courses that are required and five electives across the topical areas of regulatory essentials, medical devices, pharmaceuticals, quality and clinical.

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Online CourseOnline Course
Dual CertificateDual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,590.00 Nonmember: $4,490.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Online CourseOnline Course
Single CertificateSingle Certificate
Regulatory Affairs Certificate: Pharmaceuticals
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.
Online CourseOnline Course
Single CertificateSingle Certificate
Regulatory Affairs Certificate: Medical Devices
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Medical Devices is achieved by completing four core and five elective courses.
Online CourseOnline Course
Single CertificateSingle Certificate
Regulatory Affairs Certificate Upgrade: Medical Devices
Member: $1230 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Pharmaceuticals, you can complete the two remaining core courses of the Dual Certificate and three additional electives.
Online CourseOnline Course
Single CertificateSingle Certificate
Regulatory Affairs Certificate Upgrade: Pharmaceuticals
Member: $1230.00 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Medical Devices, you can complete the two remaining core courses of the Dual Certificate and three addition electives.

RAPS webcasts cover the trends and tools to help you maximize your regulatory efforts. Our on-demand library provides you with access to stream past webcasts and virtual events for 12 months. These webcasts offer you the ability download the presentation slides and handouts from the RAPS Learning Portal. Upon completion of the event, you can earn RAC credit for those looking to recertify.

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On-demandOn-demand
Sponsored webcast: Navigating the Complex IVDR Landscape (On-demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
This webinar will look closely at the requirements of the EU IVDR, timelines and deadlines and common pitfalls of technical documentation.
On-demandOn-demand
Sponsored Webcast: The EU Clinical Trials Regulation – Challenges Drug Developers Faced in the First 6 Months (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented.
On-demandOn-demand
Sponsored webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webinar, Certara experts Gabriella Mangino and Anaya Rehman will talk through the changes and lessons learned nearly 6 months after CTIS was implemented.
On-demandOn-demand
Mastering your 510(k) submission process (On-Demand)
1.0 RAC Credits
Member: $0 | Nonmember: $25
Understand the optimal pathway to follow for right-first-time, stress-free 510(k) clearance.
On-demandOn-demand
Sponsored Webcast: Orphan Drug Designation | The Considerations, The Rewards, and How They Differ Between The US and Europe (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why
On-demandOn-demand
Meet the Authors: Nutrition, Health, and Disease: Regulatory Policy Matters (On-Demand)
1.0 RAC Credits
Free
Meet our author and ask questions about RAPS' latest e-book, Nutrition, Health, and Disease: Regulatory Policy Matters.
On-demandOn-demand
Sponsored Webcast: Is Your Labeling an Adverse Event Waiting to Happen? (On-Demand)
1.0 RAC Credits
Price: Member: $0 | NonMember: $25
In this session we’ll explore compliant labeling, examine labeling process gaps, and provide you with the tools to defend a robust labeling process at your organization.
On-demandOn-demand
Sponsored webcast: Quality vs. compliance: moving beyond standards (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Explore how the latest industry guidance, from the Case for Quality to GAMP 5 Version 2, prioritizes quality over compliance - and why

RAPS Online courses provide you with education options to hone your skills in your area of expertise. We offer over forty courses across the topical areas of regulatory essentials, medical devices, pharmaceuticals, quality and clinical that can be taken individually.

Interested in taking more than one course? Check out RAPS Online University Bundles and Certificate Programs.

Denotes Medical Device Certificate Elective  Denotes Medical Device Certificate Elective

Denotes Medical Device Certificate Elective  Denotes Pharmaceutical Elective

Online CourseOnline Course
Pharmaceutical Labeling: Introduction to an Essential Function
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course is designed to expand the understanding of regulatory professionals about the activities, documents, and responsibilities involved in labeling healthcare products.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product development.
Online CourseOnline Course
An Essential Guide to Horizontal Role Change Thinking
Member: $95 Nonmember: $105
Sometimes the next step in one's career is not in the next-level role, but in something else. This tutorial will help you demonstrate that you can undertake a different role.
Online CourseOnline Course
An Essential Guide to Vertical Career Thinking
Member: $95 Nonmember: $105
This tutorial seeks to reframe one's thinking about expected performance. Providing insights which are typically absent or unclear from position descriptions.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Chemistry, Manufacturing and Controls (CMC) [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides an overview of the CMC section of dossiers.
Online CourseOnline Course
Dual CertificateDual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,590.00 Nonmember: $4,490.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Globalization of Clinical Research Trials and Investigations [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Effective Regulatory Communication [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.
RAC Prep BundleRAC Prep Bundle
RAC (Drugs) Flashcards
Member: $40.00 Nonmember: $50.00
Study drug terminology at your fingertips in an easy-to-use flashcard format.
RAC Prep BundleRAC Prep Bundle
RAC (Devices) Flashcards
Member: $40.00 Nonmember: $50.00
Study devices terminology at your fingertips in an easy-to-use flashcard format.
RAC Prep BundleRAC Prep Bundle
RAC (Drugs) Reference Package: Basic
Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Device) Practice Test and Flashcards together and save on these indispensable reference tools—our most popular products to help you prepare.
RAC Prep BundleRAC Prep Bundle
RAC (Devices) Reference Package: Basic
Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Devices) Flashcards and Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
RAC PrepRAC Prep
RAC (Drugs) Practice Test
Member: $85.00 Nonmember: $105.00
RAC Prep BundleRAC Prep Bundle
RAC (Devices) Prep Toolbox with Print Edition of Fundamentals of Medical Devices Regulations
Member: $1,500.00 Nonmember: $1,900.00
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC Prep BundleRAC Prep Bundle
RAC (Drugs) Prep Toolbox with Print Edition of Pharmaceutical and Biologics Fundamentals Book
Member: $1,500.00 Nonmember: $1,900.00
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC PrepRAC Prep
RAC (Devices) Practice Test
Member: $85.00 Nonmember: $105.00
RAC PrepRAC Prep
RAC (Devices) Prep Toolbox
Member: $1,250 ​Nonmember: $1,550
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC PrepRAC Prep
RAC (Drugs) Prep Toolbox
Member: $1,250 ​Nonmember: $1,550
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC Prep BundleRAC Prep Bundle
RAC (Devices) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.
RAC Prep BundleRAC Prep Bundle
RAC (Drugs) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.