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RAPS Online University provides regulatory professionals with education options to hone their skills in specific areas of expertise. We provide individual courses on a variety of regulatory topics, from the basics to product- and region-specific subjects. In order to ensure these courses are valuable and up-to-date, we recruit members to review and make recommendations on them. We are currently recruiting three (3) individuals to review the following courses:Good Laboratory Practice (GLP)This course provides an overview of GLP regulations as they are applied and interpreted by the US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA) and the Organization for Economic Cooperation and Development (OECD). This course outlines the role of regulatory bodies involved in creating and improving GLPs, all sharing the goal of achieving human safety. Students will also gain an understanding of how GLPs fit into a quality system, what types of studies are covered and how GLPs in the US and international markets align Good Manufacturing Practice (GMP)This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety. It covers a wide range of issues, including why regulations were created and are enforced worldwide, how pharmaceutical companies ensure compliance with the regulations, reasons for making quality products, US and EU regulations, the consequences for failing to comply with any regulations and associated regulatory actions.Good Clinical Practice (GCP)This course identifies the regulations on the proper conduct of clinical research with human subjects that were put in place due to ethical issues in human research; explains the role of the informed consent process in protecting human subjects; and describes the roles and responsibilities of the clinical review team. In discussing the factors that led to the development of GCPs, the course will provide an understanding of GCPs’ overall goals.Volunteers will review the course's content, as well as final assessment, and references and resources. To apply for this opportunity:
This opportunity will take approximately 8-20 hours. If selected for this opportunity, the RAPS Online University manager will reach out to you directly. RAC holders may claim RAC recertification credits upon completion of this volunteer task. The number of credits will vary for each course reviewed. The application must be received by Tuesday, 6 April 2021.
Danielle Fezell
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
raps@raps.org+1 301 770 2920
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