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Course Catalog

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 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 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 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 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 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 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 Course

Dual 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 Course

Single 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 Course

Single 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 Course

Single 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 Course

Single 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-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-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-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-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-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-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

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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 Pharmaceutical Elective

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Online 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 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 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 Course

Medical 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 Course

Pharmaceutical 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 Course

Dual 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 Course

Medical Device Certificate Elective

Pharmaceutical 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 Course

Medical Device Certificate Elective

Pharmaceutical Certificate Elective