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What is the ORAU?

The Office of Regulatory Affairs’ University (ORAU) serves a crucial function on behalf of the Department of Human Resources Development (DHRD and the U.S. Food & Drug Administration (FDA) and its various agency levels, including federal, state and local.

What Is the ORAU?

All governmental agencies have certain requirements that they need to fulfill and regulations with which they must comply as part of their duties. With such requirements, it is important that each member of staff for the respective entity is familiar with the most current training and guidelines.

The Office of Regulatory Affairs’ University allows the DHRD, which oversees the various entities of the FDA, in terms of regulatory issues, to ensure compliance. The FDA lists the ORAU as a combination of brick, or face-to-face coursework, and click, which indicates online studies and activities. The click training portion gives the employees the chance to dig deeper into coursework since they can access various web-based training, web conferences and seminars, video conferences and satellite broadcasts.

What Training Issues Does ORAU Include?

One of the fundamental training issues that ORAU addresses is succession planning, which involves devising and implementing a workable strategy for each regulatory community. Since this is not a static concept, employees need to periodically attend meetings to reassess the succession plan and try to find ways to make improvements.

The ORAU (“the University”) also addresses strengthening basic skills and knowledge, helping employees understand the uniformity of the regulatory process, providing uniform training from one agency to the next, and keeping up with the latest technology available to each regulatory community. Additional training issues that the University addresses include recruitment and retention tools, increased flexibility and access to training, effective and efficient training, and ensuring the right people receive the right training at the right time.

Why Is the ORAU So Important to the FDA?

Like many regulatory communities, the FDA and its employees have a full roster of regular daily responsibilities to attend to, specific to the governmental branch. The ORAU allows everyone to stay sharp on supplementary–yet still critical to operations–matters. The FDA notes that the “ORAU can be viewed as a clearinghouse where FDA staff and state and local regulators can go for traditional and new technology training and development.”

What Are Some of the Policies for Classroom Based ORAU Courses?

Students who prefer attending class training sessions, or if certain courses are only available via the classroom, there are a number of policies for students to check at the website, including the following:

  • Courses are tuition-free.
  • Contact the course registration representative at least 60-days in advance of the course date.
  • The respective agency is responsible for travel and accommodation fees.

It is important that students follow the appropriate policies to ensure registration and attendance so they can seamlessly continue complying with relevant regulations to their community.

What Are Some of the Policies for Web Based ORAU Courses?

FDA employees can find more detailed information about specific courses via their Intranet ORAU website. Additionally, FDA staff can access the information in remote locations, outside of the network, by logging in to Compliancewire, using their log on information.

What Are Some Types of Courses Offered Through ORAU?

ORAU training courses include subjects like updates in food allergens, communication skills for regulators, food security awareness, and food labeling.

The ORAU Helps Keep FDA Employees Informed to Keep the Public Safe

The Office of Regulatory Affairs’ University is as important to the public as it is to employees since it helps them maintain focus on daily tasks while complying with key regulations.