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: $3,625.00 Nonmember: $4,535.00
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: $2380.00 Nonmember: $2980.00
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: $2380.00 Nonmember: $2980
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: $1245 Nonmember: $1555
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: $1245 Nonmember: $1555
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
Leveraging Technology to Drive Strategic Impact
1.0 RAC Credits
Member: $0 | NonMember: $25
Join a dynamic discussion with regulatory affairs leaders from pharma and biotech on leveraging technology to drive strategic impact. Hear first-hand how these leaders are making a difference.
On-demandOn-demand
RAPS Webcast: Optimizing Standards for Regulatory Use (On-Demand)
1.0 RAC Credits
Price: $0 Member | $25 NonMember
This webcast will feature an FDA presentation on how consensus standards can be improved in order to better allow manufacturers to cite them appropriately in device submissions.
On-demandOn-demand
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling (On-Demand)
1.0 RAC Credits
Price: $0 Member | $25 NonMember
In this webcast, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance.
On-demandOn-demand
Sponsored Webcast: How Drug Developers Can Navigate the Inflation Reduction Act (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
This webcast provides a thorough explanation of the Inflation Reduction Act. By attending, regulatory professionals and manufacturers can better comply with the new regulations.
On-demandOn-demand
Meet the Author: Risk Management Principles for Devices and Pharmaceuticals, Third Edition (On-Demand)
Member: $0 | NonMember: $25
This book aims to document the rules and regulations regarding peri- and post-marketing risk management principles and practices.
On-demandOn-demand
RAPS Webcast: MDR by The Numbers (On-Demand)
1.5 RAC Credits
Member: $0 | NonMember: $25
MDR implementation cold, hard, numbers: results of research on recent MDCG guidance, industry and Notified Body surveys, and interviews with stakeholders (including NB) on experiences with implementation.
On-demandOn-demand
Insights and Actions from the 2023 Medtech Regulatory Performance Report Event (On-Demand)
1.0 RAC Credits
Price: $0 Member | $25 NonMember
The 2022 Medtech Regulatory Performance survey of 200 medtech regulatory professionals yielded some expected and some unexpected results. We will explore the findings and regulatory predictions for 2023.
On-demandOn-demand
RAPS Webcast: Streamlining Conformity Assessment in Device Submissions: FDA’s ASCA Program (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Introductory webcast for participants to the webcast for participants to the FDA's ASCA, a program in which manufacture.rs may contract with ASCA-accredited test labs to perform testing to certain consensus standards

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
Regulatory Writing: Building a Successful Culture for Collaborative Writing
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course explores the barriers to effective teamwork on interdisciplinary teams, along with identifying strategies for timely, relevant, and understandable communication.
Online CourseOnline Course
How to Conduct a Regulatory Pathway Assessment Series: FDA 101 Navigating the FDA for the first time
1.0 RAC Credits
Member: $150.00 Nonmember: $200.00
This first course introduces FDA risk-based device classifications, FDA product codes, regulatory controls and the five steps to market for a new medical device.
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
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: $3,625.00 Nonmember: $4,535.00
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.