A powerful new tool is available to FDA through a first-of-its-kind cooperative research and development agreement (CRADA) between FDA and EduNeering, a developer of computer-based compliance training systems.
A powerful new tool is available to FDA through a first-of-its-kind cooperative research and development agreement (CRADA) between FDA and EduNeering, a developer of computer-based compliance training systems. That collaboration has resulted in a "virtual university"-dubbed ORA U after FDA's Office of Regulatory Affairs (ORA)-the agency's new online training program for inspectors and investigators. The collaboration is unique in that it makes the same educational content available to pharma companies.
Like corporations, FDA needs to do more with less. For both the public and private sectors, constantly expanding responsibilities have run headlong into tightening budgets, forcing managers to search for better ways to handle all functions, including training.
Several years ago, the Office of Regulatory Affairs began a process to standardize and enhance training for more than 4,000 of its own staff and for several thousand state and local regulatory agency employees charged with enforcing FDA regulations for food, drugs, and other commodities. That initiative dovetailed with provisions of the Federal Technology Transfer Act, which encourages agreements between government agencies and the private sector to promote collaborative research and development.
ORA's agreement with EduNeering, signed in 1999 and renewed last summer for a minimum of another five years, laid the groundwork for what would become a collection of 110 online courses, with more yet to come. (See "ORA University-A Sampler," page 82.) FDA developed and reviewed the content of those courses and provides the internet access for its students. EduNeering provided the e-learning technology as well as the instructional design, programming, and technical support for the web-based system. The company also provides a learning management system to track, document, and manage the program so FDA administrators can have access to up-to-date information about each student's progress.
Although ORA U's most important function is to support ORA's Inspector Certification Program, the pharma industry can benefit as well. The same system and courses used at ORA U are also available to all FDA-regulated companies-including pharma, biotech, and medical device manufacturers. (See "Sign Ups and Certification," page 80.)
ORA U takes a "brick and click" approach: face-to-face courses and activities combined with distance e-learning including web-based training, satellite downlinks, and teleconferences. Each multimedia course offered through ORA U is interactive and uses cutting-edge instructional design plus narration to create a stimulating learning environment. (See "Learning on Demand," page 83.)
The courses are also extremely efficient. The average training module takes 30–40 minutes to complete and is the equivalent of two-and-a-half to three hours of classroom instruction. And students can take the training on their own time, bookmarking each course so they can return to it for study and review.
That "blended learning" model has served FDA well since the first courses went online in December 2001. The numbers speak for themselves: FDA had 3,392 participants who completed 343 online courses in 2001. The virtual university increased the number of participants by 16 percent to 3,927 in the first quarter of 2002 alone. By the year's end, ORA U students had completed more than 80,000 online training activities including more than 30,000 web-based courses. Perhaps most telling, the 600 new inspectors FDA hired at the end of 2001 needed only three months to complete the basic training, compared with the previous standard of 6–12 months. Throughout their careers, inspectors will continue to have access to more advanced courses through ORA U.
Currently, nearly 5,000 FDA employees from ORA and the agency's five regulatory centers are enrolled in the system. Within the next 18–24 months the courses will roll out to all state and local regulators as well, eventually boosting the total number of enrollees to 50,000. There are now more than 2,000 state and local regulators enrolled from 159 agencies and 49 states."
Blended learning incorporates both traditional instructor-led training and web-based courses to provide the best possible training to the largest possible audience. Many organizations are hesitant to implement web-based programs because of negative experiences with the technology when it was first introduced. But during the past few years, online learning has changed dramatically. (See PE, "E-Learning Goes Interactive," May 2002.)
In early experiments, providers simply moved established classroom training online without considering how to redesign content for the new medium. Such courses consisted of volumes of text, talking heads, and electronic paper-and-pencil tests. Fortunately, the teaching strategy evolved over time to engage students by organizing content into smaller, more meaningful segments and incorporating extensive student feedback.
Online training has proven successful, both in imparting skills and in helping students achieve desired levels of competency. ORA U uses satellite downlinks and teleconferences to create an interactive program that is stimulating to students and easy for managers to document.
Ever-changing industry technology calls for frequently updated training, which can be difficult to achieve with traditional methods. But ORA U's variety of techniques allows its web-based components to deliver current information almost immediately. Those up-to-date modules enable both FDA trainees and pharma companies to stay abreast of the changing regulatory environment. ORA U's ability to provide consistent instruction also ensures that US inspectors and investigators share a common base of knowledge and maintain identical inspection procedures and standards throughout the country.
ORA U's format accommodates diverse training needs with modules that incorporate a series of unique programs, ranging from the basics of investigation to food and drug law, good manufacturing practices, quality system regulations, good clinical practices, and computer software validation, among others. ORA U also offers participants a complete curriculum consisting of complementary learning experiences including classroom, web-based training and exercises, discussion, and on-the-job training.
In addition, ORA U allows companies to access the same content and curricula FDA uses to train its inspectors and investigators, keeping FDA and the industry on the same page. Most important, the virtual university is not a static program but a constantly evolving learning system with new modules coming online as needed.
Under the old frame of reference, managers measured a training program's effectiveness by the number of hours it ran. But today the benchmark is performance, not only for regulatory compliance, but also for internal cost/benefit analyses and for adherence to worldwide standards, such as those set by the International Standards Organization.
Too often, the relationship between regulator and regulated has been, or seemed to be, adversarial. But through ORA U, the private sector can take a seat at the training table with FDA, with access to the same content. Agency inspectors and investigators gain consistent training, and pharma companies come away with a greater understanding of how FDA inspectors are trained. Everyone benefits.