Solutions Paper
September 2007
202 Carnegie Center Suite 301 Princeton, NJ 08540 609-627-5300
How Industry Benefits from FDA’s Online Training Program
by Janice McFarland, Senior Vice President, Kaplan EduNeering, Inc.
With public and legislative scrutiny of the US FDA and FDA-regulated organizations at an all-time high, companies have a strong incentive to re-examine the training initiatives that support their regulatory compliance and financial security. Through its Office of Regulatory Affairs and Kaplan EduNeering, FDA’s “virtual” university (ORA U Online) ensures the competency of more than 30,000 federal, state, and local investigators. Kaplan EduNeering is FDA’s longtime partner in creating, administering and continually expanding ORA U Online. The same technology and knowledge resources used by FDA are available to the regulated community through a unique agreement with Kaplan EduNeering. This paper examines the technology and curricula chosen by FDA – and the competitive advantage for businesses that adopt the same program to ensure the compliance and performance of their workforce.
FDA’s regulatory mission, including enforcement, is directed by its Office of Regulatory Affairs (ORA), which ensures the implementation of FDA’s public health standards. Despite a consistent reduction in its budget over the past two decades, ORA inspected more than 2,400 pharmaceutical facilities and 1,800 biologics facilities in 2006. Under pressure to fulfill its mission of protecting the public health under a tightening budget, ORA is undergoing a reorganization focused on quality management and risk management approaches. A key element of ORA’s reorganization is an emphasis on targeting inspections to those industry operations and facilities identified as posing the greatest risk to human health. Along with that shift in focus, FDA is expanding the number of its inspectors and investigators, signaling a corresponding
increase in its inspection and enforcement activities. Like FDA-regulated companies, the Agency recognizes its reliance on the knowledge of investigators to fulfill FDA’s responsibility for ensuring safe products. To ensure that this ever-growing enforcement knowledge is shared consistently among federal, state, and local investigators, ORA depends on ORA University (ORA U), its multi-format training program. The cornerstone of ORA U’s ability to assure competency among 30,000 learners is the online learning component of ORA U (referred to in this paper as ORA U Online), which enables ORA to provide, test, document and manage training for personnel regardless of their location. The value of ORA’s online training extends far
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beyond the Agency. Through the innovative public-private partnership with Kaplan EduNeering that launched ORA U Online in 1999, the same technology platform and online learning resources integrated into ORA U are available to FDA-regulated industries. ORA U Online is, in fact, as important to the regulated industry as it is to regulators. The evolution of ORA U Online highlights ORA’s application of technology to the training challenges faced by many companies with dispersed facilities, increasingly sophisticated products, and global workforce. It illustrates an innovative approach that has reduced ORA’s training costs by thousands of dollars per trainee and it provides a roadmap for companies in obtaining practical business benefits from ORA’s experience and resources for industry.
ORA began reorganizing its burdensome training system by integrating the parallel training functions into a centralized department. While that move improved administrative efficiencies and standardized the knowledge expected of inspectors and investigators, the consolidation of systems did little to reduce training costs or to allow the flexibility demanded by new and rapidly changing regulations. By the early 1990s ORA introduced a newer approach – one that was emerging in the business world but was revolutionary in government at that time. The approach replaced the common emphasis on “training” with a dynamic focus on “learning.” Instead of a traditional, reactive approach to training, ORA set the stage for an innovative, proactive approach that linked learning to the strategic thinking and policies of FDA.
The Basis of ORA U Online
FDA’s efforts to achieve greater efficiencies in the training of its workforce spans more than 20 years. In the early eighties, ORA was burdened by a system that was both costly and unable to respond quickly to changing needs and regulations. Investigators were trained under a two-pronged system in which ORA field personnel were trained directly by ORA, while state investigators were trained on an unstandardized state-by-state basis. Complicating this uneven knowledge foundation among investigators were these factors: • the seemingly constant issuance of new regulations and guidance; • the geographic dispersion of investigators; • the inability to provide near-simultaneous instruction; • the high travel and administrative costs associated with conducting classroom training; • and finally, the absence of any mechanism to measure learning results or investigator proficiency.
Underlying ORA’s new approach was an appreciation for the learning potential of technology. ORA’s first foray into technology-enabled learning was through the use of videotapes projected to distant learners via satellite. The results of the fledgling effort were notable. Instead of a handful of people learning in a classroom setting, some 5,000 people in dispersed locations were able to take the first course in food safety; all learners received standardized training; and the cost of training was reduced several thousands of dollars per learner. With a goal of training 30,000, however, ORA was still far short of its goal for standardized competence.
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Introducing the CRADA
The US Congress’ enactment of the National Technology Transfer Advancement Act in 1995 promoted greater interactions among Federal laboratories, state and local governments, universities and the private sector. This expanded cooperation was enabled through the newly established Cooperative Research and Development Agreement (CRADA). From its introduction, the CRADA has been used to develop and commercialize innovative research-based products. The CRADA had never been applied to a “learning” technology. FDA entered into its first learning technology CRADA in 1999 when it partnered with Kaplan EduNeering to develop an online component of its training program. Kaplan EduNeering was uniquely positioned to partner with ORA in an initiative that integrated technology, learning and FDA’s “business” model. EduNeering was making a mark in the field of distance learning through its proprietary technology platforms and use of advanced instructional design in its coursework. Equally important, EduNeering was willing to commit substantial resources and time to developing, refining and upgrading a program that had never been attempted at FDA.
practical benefits in both efficiencies and range of functions: • ComplianceWire employs an Application Service Provider (ASP), or hosted, model that transfers most capital, operational and maintenance costs for the system’s hardware and software to Kaplan EduNeering while enabling FDA to maintain oversight and management control. Equally important, the technology platform provides optimal support to and for remote users, enabling them to access learning resources through ORA U Online from any computer as long as they have security clearance.
• ComplianceWire technology is interoperable with other IT systems, including those used for document management, enterprise resource management, clinical trials, human resource management
The Technology Platform
The basis of ORA U Online was, and remains, ComplianceWire®, the Part 11-validated technology platform Kaplan EduNeering developed specifically for the FDA-regulated community. Unlike many technologies available at the time, ComplianceWire incorporated versatile capabilities beyond computer-based training courses. ComplianceWire enabled the targeted distribution of courses, testing for comprehension, and validation by esignature. In addition, it armed ORA managers with realtime oversight capabilities and documentation in auditready format. Since then, ComplianceWire has evolved into a robust, versatile solution that currently is used by more than 100 FDA-regulated organizations. ComplianceWire’s versatility, scalability and consistent increase in capability have enabled ORA to achieve
and other learning management systems. Through integration with an organization’s document management system, for example, ComplianceWire enables automatic triggering actions for employees when any document update is available, supporting a more efficient compliance program for distributing and tracking SOPs and other critical documents. Once alerted, employees must demonstrate understanding of the distributed materials through electronic quizzes. • ComplianceWire provides complete compliance with 21 CFR Part 11. It incorporates all constructs defined by Good Automated Manufacturing Processes (GAMPs) and GXPs including those related to electronic records and signatures, audit logs, record versioning, data security, and support of
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How Industry Benefits from FDA’s Online Training Program
quality systems. • FDA’s changes in organizational structure or operational priorities are readily accommodated by the versatility of ComplianceWire, which enables training to be targeted based on employee roles, job functions, location or department. ComplianceWire arms ORA with optimal monitoring and management capabilities. Based on defined parameters, managers can monitor a broad range of training activities and employee learning status in real time. The program’s monitoring component has been used to aid in manpower planning by identifying employees with master-level knowledge and allowing them to be easily reassigned where needed. • ComplianceWire serves as a core platform and extension of comprehensive learning programs for employees and external subcontractors that include blended learning, instructor-led, hands-on demonstrations and mentoring components. • ComplianceWire’s Critical Information Control System (CICS®) functionality can assign, track, and document information and learning materials hosted or created by client organizations. CICS delivers SOPs, policies, procedures and other critical documents to employees and external partners, and records and acknowledges receipt, understanding, and/or acceptance. • •
reflect changes in policy, procedure and approach. These courses incorporate the most current, accurate content available anywhere. The collective learning requirements for investigators create a roadmap for regulated organizations to follow in their own learning programs. In addition to a company’s standardized compliance courses, the ORA U Online courses focus attention on topics such as “Introduction to Quality Systems Regulations” and “Conducting An Annual Product Review.” These courses can provide regulated organizations with deep insight into the intentions and expectations of FDA investigators.
The ORA U Online curricula are extensive and constantly expanding. They now include more than 100 courses in topics extending from broad-
FDA-Authored and/or Reviewed Curricula
The FDA’s CRADA with Kaplan EduNeering provides unusual benefits to the regulated community, including access to the same learning content used to train FDA inspectors and investigators. These online courses reflect the most current thinking, requirements and expectations of FDA inspectors and investigators, enabling regulated companies to target their own knowledge needs quickly and accurately. • Courses are developed by Kaplan EduNeering based on materials and information provided directly by ORA. Courses are regularly updated to
based regulations (GMP Principles for Standard Operating Procedures) to specific scientific standards (Gowning for Sterile Environments.) Discrete curricula have been developed for medical device, pharmaceutical and biologics organizations across GMP, GCP, Sales & Marketing, and other subject areas. For example, learning resources include a 45-course library on FDA Inspections and Enforcement, which provides targeted knowledge about the inspection process, inspector expectations, and management requirements for company employees before, during and after an FDA inspection.
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Standardized ORA U Online courses can be customized by individual organizations as needed to target the knowledge needs of employees, subcontractors, partners and vendors. Additionally, organization-specific instructional and design elements range from displaying company proprietary products to customizing various languages and cultural sensitivities.
ORA Certification
Certification is becoming an increasingly important consideration for FDA to ensure the competency of its inspectors. Interestingly, it is also becoming an important factor for life science companies in some areas of their operations. Access to hospitals and other clinical environments by sales representatives, for example, is increasingly restricted as healthcare facilities impose new certification requirements as part of their efforts to ensure patient safety and achieve compliance. To ensure that all ORA investigations and enforcement actions are based on consistent, agency-wide knowledge, ORA has created a performance-based certification program that reflects best-in-class technology and management. The multi-stage certification process relies heavily on ORA U Online and includes: • Proficiency standards, identified by subject matter and completion schedule, are required of all investigators; • Interactive challenges are offered at the completion of each course, which help to ensure comprehension of subject matter. These challenges are specifically designed to prepare learners to qualify for the next course. • Independent auditors conduct regular audits of certified field personnel to determine proficiency in key subjects, policies and procedures for conducting inspections, and individual requirements of the auditor; • A second audit is performed by an ORA trainer to ensure that there is no conflict of interest between the investigator and the independent auditor; Not all learners meet the certification requirements, because ORA’s approach is based on demonstrated performance rather than course completions. As a result of its rigorous standards, ORA U Online’s web-based and classroom courses are approved for continuing education by the International Association for Continuing Education Training (IACET).
ORA Moves Forward
In 2006 ORA extended its CRADA with Kaplan EduNeering for five years. The extension expands ORA access to new EduNeering technologies that increase ComplianceWire functionality beyond ORA’s original uses. Among the new capabilities: • CV BuilderSM allows organizations to manage the Curriculum Vitae (CV) of employees. Fully integrated with ComplianceWire, CV Builder creates a single, secure repository for all CVs in a consistent format, providing employees with a central location to update job-specific credentials and giving managers a practical tool to collect employee information prior to audits and reviews, as well as for manpower planning.
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Visual Job AidSM (VJA) is a training and reference aid that provides employees with consistent guidance for processes, procedures and best practices. Using text, sound, video clips, graphics, animation and interactivity, Visual Job Aid facilitates on-the-job or just-in-time learning. VJA is an especially valuable tool for training of undocumented procedures, processes or experiential knowledge, or for employees for whom English is not their primary language.
and constraints. Because of those rapid changes and evertightening budgets, ORA needed a learning solution that was adaptable, robust and responsive to new conditions. Just as important, as a condition of the CRADA, ORA required a solution that would offer value to the regulated community. Today’s ORA U Online accomplishes both objectives. As an added benefit, ORA has acknowledged that for new inspectors, initial training time has been reduced on average by more than 50% since the launch of ORA U Online, from six to 12 months to three months. The ComplianceWire technology platform and curricula are now used by the regulated community to ensure the competency of more than one million learners. These resources, which were initially adopted by many FDA-regulated organizations solely to improve their compliance efforts, now are employed to improve operational performance, support employee learning and development, oversee the activities of subcontractors, promote corporate culture and communication, and establish a consistent level of knowledge across increasingly global enterprises. The ability to retain a competitive business advantage increasingly relies on the ability of an organiza-
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Virtual Audit is a tool being developed for pre-, during- and post-inspection activities to ensure that investigators are targeting the areas of highest risk. Simulation technology will be employed to “walk” the investigator through a manufacturing facility.
tion to quickly, accurately and cost-efficiently address increasingly sophisticated knowledge requirements with a workforce that is global, mobile and intolerant of traditional training approaches. FDA has created a powerful, flexible learning model that benefits the agency and taxpayers through its efficiency, but that also provides industry with a proven
A Focus on Learning
Like science, technology and business, ORA is constantly confronted by new challenges, requirements
learning solution that serves the specific needs of the FDAregulated community, from regulatory compliance to operational efficiency and workforce performance.
202 Carnegie Center Suite 301
Princeton, NJ 08540 609-627-5300
www.kaplaneduneering.com
Kaplan EduNeering (www.kaplaneduneering.com), is part of Kaplan, Inc., a leading international provider of educational and career services that is a subsidiary of The Washington Post Company (NYSE: WPO). Kaplan EduNeering develops technology-enabled knowledge solutions for improving business performance and assuring regulatory compliance. Kaplan EduNeering is headquartered in Princeton, NJ, and has offices in Houston, TX, Bloomsburg, PA and London, UK.
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