Compliance Training: Cost Efficiencies of Off-the-Shelf elearning

Compliance Training: Cost Efficiencies of Off-the-Shelf elearning IN THIS PAPER: Comparing the Cost of Buying vs. Developing elearning Compliance Courses

Compliance Training: The Economics of elearning When we talk to dozens of QA and Corporate Compliance Trainers, they share their biggest challenge: they simply don t have enough hours to develop and deliver all the compliance training topics that the company - and regulations - demand. For example, we discussed this issue with a three-person training team developing training programs based on 60+ regulations and 500+ companyspecific SOPs/work instructions. This training content is designed for many roles in the Life Sciences organization, such as QA, engineers, designers, line operators, service technicians, lab specialists, warehouse, etc. That s why many compliance training teams have embraced blended learning, in which elearning courses related to compliance topics are aligned with face-to-face classroom events. In many cases, clients have shifted foundational 60-minute classroom training activities into 30-minute elearning courses, using today s course authoring tools. We estimate that when a training event shifts from classroom to elearning, both the trainer and the learners gain an additional 100 hours annually (that s assuming an organization of just 200 learners). When considering employee salaries, this shift to elearning saves $6,000 worth of employee time, and for trainers, this means more time to dedicate to company-specific training programs. In this paper, we explore the question that training teams ask us of elearning: rather than developing all of the content in-house, does it make economic sense for the training team to purchase foundational compliance courses from a third-party vendor? Page 2

Cost Efficiencies of Off-the-Shelf elearning FACE-TO-FACE 60-Minute Classroom Training TECHNOLOGY-ENABLED, IN-HOUSE 30-Minute DIY elearning Course 76 210 $ 17,160 85 100 $ 11,100 Development Training COST Development TECHNOLOGY-ENABLED, VENDOR 30-Minute Off-the-Shelf elearning Course 0 Development 100 Training $ 9,620 COST Training COST Over 80 Hours Gained for the Training Team In many cases, an elearning course takes more time to develop than a classroom event. But the trainer doesn t have to set up and conduct the course in multiple face-to-face events, which can make the elearning course a more cost-effective approach. Our clients tell us that when they purchase a compliance course from a third-party vendor, rather than develop it themselves (DIY), they are able to remove core compliance topics off the course development list. As a recent Lynda.com report noted: Producing learning content consumes time. If a course can be accessed without having to put more time into its development, ROI increases. 1 Considering the training team expense, puchasing a single elearning course frees up 80 hours, as responsibility for these activities shifts to the vendor: researching the regulations, establishing learning objectives, writing the course script, crafting the assessments, assembling the content in a content authoring tool, testing the course, and maintaining the content. In 2009 Dr. Karl Kapp partnered with ASTD (The Association for Talent Development) organization (now ATD) to survey training teams, and learned that on average, trainers need 91 hours to build a classroom event. Furthermore, the study noted that it takes 126 hours to develop a 30-minute online training course. 2 Using the UL Learning Solutions team as a gauge, we estimate that a typical 30-minute elearning compliance course takes about 65 hours to develop, based on efficiencies and advancements in our own authoring tool. And we must reflect maintenance hours to keep the course current. Our clients have reported that it s typical for their training team to need 50 hours to develop a one-hour classroom event, and we used that number in our analysis. We also added the activity of recording and grading test results in the classroom activity time, as this is managed within the elearning course. More details and assumptions are provided at the end of this paper. Page 3

Cost Efficiencies of Off-the-Shelf elearning How Costs Were Calculated In the following calculations, we compare the costs of developing and conducting a 60-minute classroom event to developing a 30-minute elearning course. We use the employee cost based on salary, health insurance and related employment expenses. In the third chart, we show the costs associated with an off-the-shelf 30-minute elearning course, and replace the internal development costs with the elearning subscription price. Here are some assumptions we ve made in these calculations: 200 employees require the classroom training, and sessions of 20 employees are given; Training administration and completion equals $60 an hour (fully loaded employee cost); For classroom events, costs associated with travel and lodging were not included; For building elearning, the costs associated with the purchase of the content authoring tool were not included; Learning effectiveness of the classroom event is equal to that of elearning; The 30-minute elearning off-the-shelf cost is $17.50 per user annually, or $3,500 for 200 learners. Developing and Conducting a 60-minute Classroom Event (200 Learners) Activities: Hours Cost* Developing Training Content (Research, Writing, 50 $3,000 Building Powerpoints & Quizzes, etc.) Scoring and Recording Assessments & 16 $960 Completions Maintaining Courses as Regulations Change 10 $600 Conducting the training (10 sessions) 210 $12,600 TOTAL 286 $17,160 Building and Delivering a 30-Minute elearning Course (200 Learners) Activities: Hours Cost* Developing the Course (Research, Building 65 $3,900 content in an authoring tool, output to an LMS) Assigning courses and recording Assessments & 2 $120 Completions Maintaining Courses as Regulations Change 18 $1,080 Conducting the training 100 $6,000 TOTAL 185 $11,100 Purchasing and Delivering a 30-Minute elearning Course (200 Learners) Activities: Hours Cost* Developing Training Content (Research, Writing, N/A $3,500 Building Powerpoints & Quizzes, etc.) Assigning courses and recording Assessments & 2 $120 Completions Maintaining Courses as Regulations Change 0 $0 Conducting the Training 100 $6,000 TOTAL 102 $9,620 * Salary & expenses Page 4

Cost Efficiencies of Off-the-Shelf elearning How Off-the-Shelf elearning Courses Are Cost-Efficient In our analysis, purchasing a single elearning course saves approximately $1,500 vs. developing the same elearning course using internal resources. While this is a significant cost savings, companies should also consider the opportunity costs associated with the training team. Clients would eliminate 83 hours of training administration and development time when they purchase a single 30-minute elearning course versus building the course on their own. UL has identified 20 foundational compliance training topics that our 350+ Life Sciences clients typically use on an annual basis. Based on our analysis, a company using all 20 courses would reduce their development costs by $30,000. In addition, purchasing these courses would free up 1,660 hours for the training team so they can focus on critical internal product- or process-based training that s unique to the organization. When we work with 300+ clients who are struggling to build compliance training, we routinely find the training team spends many hours developing and delivering foundational compliance training programs, such as those courses focused on key regulations. When training teams are able to transition this foundational training to off-the-shelf courses, they are able to redirect their efforts to developing more company-specific training. From the learner perspective, studies have shown that elearning fosters greater satisfaction. For example, a recent study revealed that corporate employees value the fact that elearning courses enable them to acquire knowledge at their own pace. 3 What s more, training delivery time is improved with elearning, which may also result in improved performance at a faster rate. One elearning study demonstrated that company-wide processes were introduced to employees 12 months sooner as compared to when the company used classroom training activities. 4 An Assumption: elearning is Equally Effective In our analysis, we considered the time it takes to both develop and take a learning activity. We need to acknowledge, however, that we assumed in our analysis that classroom learning and elearning delivered the same outcome. That is, the learners were able to apply the knowledge from the activities. We know that in some cases that training outcomes are different, depending on the type of training used, and the topics presented. There have been many articles and studies that have looked at the pros and cons of both training types. In a UL whitepaper, we promote a blended learning approach, in which both types are used within the same program. The basic fundamentals are provided in an online format, and advanced skills are delivered in a classroom environment. And we know that some experts have encouraged organizations to conduct two comparable studies for both elearning and classroom activities, using the same calculation process, in which a string of benefits and costs is developed for both learning types. 5 Page 5

Cost Efficiencies of Off-the-Shelf elearning Typical Off-the-Shelf Compliance Topics Clients use these courses to reduce the effort of the training team to deliver continuous regulatory expectations, as they pertain to specific GMP regulations, GCP regulations, federal laws and industry standards. Some clients have shared with us other values of GMP elearning programs: Employees gain additional training touch points, helping learners understand why a company focuses on meeting regulatory obligations, thus empowering them to be more proactive; Employees are able to rise above the day-to-day activities to see the bigger picture, improving quality culture; specifically, GMP elearning training which provides extra motivation to line managers, operators and even knowledge workers to focus on quality issues, risk management, visual inspections, data integrity, etc. UL reviewed our extensive database on standard elearning course completions to identify the following foundational compliance course topics. The topics cover key areas, including Quality Assurance, Clinical Operations, Corporate Compliance, Environmental, Health & Safety, and Human Resources Compliance. While this list is not exhaustive, we have categorized our top 25 courses based on the typical training owner within a Life Sciences company. Quality/GMP: Introduction to GMP Principles Good Documentation Practices Change Control Principles Gowning for Sterilized Products Quality Risk Management Principles (ICH Q9, ISO 14971, etc.) Regulatory Inspection Readiness Basics of Corrective and Preventive Actions (CAPA) Validation: Process Validation Part 11 Validation for Electronic Records & Electronic Signatures Anti-Bribery (FCPA) Conflicts of Interest Data Privacy Corporate Compliance: HR Compliance: HIPAA Regulations Adverse Events Fraud Prevention Harassment for Employees Harassment for Managers Diversity and Discrimination in the Workplace Clinical Operations: Introduction to Good Clinical Practices Role of the Clinical Research Associate Informed Consent Role of the Data Study Coordinators Environmental, Health & Safety: Hazard Communication Electrical Safety Personal Protective Equipment Page 6

Cost Efficiencies of Off-the-Shelf elearning Summary As training administration teams are asked to conduct a growing number of training topics, often with less resources, the shift to off-the-shelf compliance-focused courses makes economic sense. However, the real advantages should be measured by time saved. With each foundational compliance course used, an organization can save approximately $1,500 in development costs and $5,000 in opportunity costs, as the purchased course frees up over 80 hours of course development time for training teams, enabling them to focus on topics that are either unique to the organization, or that demand advanced training that can only be conveyed via a classroom setting. Should a company select just 20 foundational Quality & Compliance courses from UL, for example, the organization would save $30,000 in development costs and almost $100,000 annually as it relates to salaries alone. As some clients have noted, this is equivalent to adding a staff member to a training team. Moving forward, we will examine how to measure other advantages of elearning, such as the ability to standardize testing to remove bias, and quicker training delivery time. Page 7

About UL Compliance to Performance UL Compliance to Performance provides knowledge and expertise that empowers Life Sciences organizations globally to accelerate growth and move from compliance to performance. Our solutions help companies enter new markets, manage compliance, optimize quality and elevate performance by supporting processes at every stage of a company s evolution. UL provides a powerful combination of advisory solutions with a strong modular SaaS backbone that features ComplianceWire, our award-winning learning and performance platform. UL is a premier global independent safety science company that has championed progress for 120 years. It s more than 12,000 professionals are guided by the UL mission to promote safe working and living environments for all people. References: 1 Building Successful Corporate elearning Programs, Lynda.com, January 2015 2 The Costs of Blended Learning, Karl Kapp, ASTD, 2009 3 Corporate elearning Impact on Employees, Prince F. Ellis, Brown Mackie College - Cincinnati Kevin D. Kuznia, Ashford University, Global Journal of Business Research, Vol. 8, No. 4, 2014 4 How E-Learning Can Increase ROI for Training, Thinq Corporation, 2000 5 The Business Value of elearning, Dr. Jack Phillips and Holly Burkett, elearning, January 2008 202 Carnegie Center Suite 301 Princeton, NJ 08540 609.627.5300 UL and the UL logo are trademarks of UL LLC 2015. ULComplianceToPerformance.com WP/15/102715/LS