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.
Regulatory Basics Bundle
The courses provide fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets. Paired together, these courses serve as an excellent foundation for regulatory affairs knowledge.
Regulatory Medical Writing Bundle
Regulatory and medical writing is an integral part of the product development and approval process. It is a skill that must be honed and refined as you gain regulatory knowledge and experience. Learn more about the components of various application types and techniques for improving document quality.
Clinical Trial Foundations Bundle
Looking to improve your knowledge surrounding the proper conduct of clinical research with human subjects? You’ll learn more about the fundamental requirements for major markets, the role of the informed consent process, types and phases of clinical trials and protocol development, roles and responsibilities of parties involved in clinical research and issues related to trial management and safety monitoring.
This three-course series examines essential topics within a quality system--Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). The GxP Bundle details the areas covered by each set of requirements and compares US and international regulations. The topics provide the foundation for product quality--critical knowledge for new professionals in regulatory, quality assurance, compliance or related departments such as laboratory management or clinical operations.
Medical Devices Postapproval Bundle
The Medical Devices Postapproval Bundle links together three critical regulatory compliance activities following completion of the medical device product realization process --post market surveillance; post-release risk management; and corrections, removals and directed recalls. Intended for experienced regulatory, quality systems, medical affairs, legal, compliance management, and product development engineering personnel, this set of courses provide an examination of the applicable regulations, requirements and health authority reporting criteria across each of the three areas for the US, Canada and European Union.