UL EduNeering Online Compliance Training Blog

Technology Best Practices and Trends in Compliance

The Knowledge Summit provided great information with Carla O’Dell’s presentation as well as some great client presentations outlining the effective use of technology to help ensure compliance and safety within an organization.

Towards the end of the first day, a number of presentations were provided which gave insights into what EduNeering has been doing in a number of areas and how they are tracking the evolving field of compliance and regulatory training requirements.

• The EduNeering Platform Roadmap
• Technology Best Practices
• Regulatory and Compliance Trends

This blog posting covers the Technology Best Practices and Regulatory and Compliance Trends. The fourth posting in this series will discuss the Platform Roadmap and the presentation by Dan Lyons, Newsweek Technology Editor and wrap up Knowledge Summit.

Todd Hohm VP Strategic Resources, discussed Regulatory and Compliance Trends and provided some stark figures in terms of areas that have improved and areas that still need improving. He indicated that the number of overall workplace injuries is down but, on the other hand, the cost of workplace injuries are up. He also provided a list of Top Ten Trends in Environmental, Health and Safety:

• Rising Healthcare Costs
• Aging Workforce Demographics
• Compliance- greater complexity, stiffer penalties
• Governance and Transparency
• Brand/Goodwill Protection
• Sustainability Globalization/Competitive Pressures
• Outsourcing and Reduction in Vendors
• Data Driven Decision Making
• Adoption of new loss prevention methods.

Ellen Leinfuss, SVP, Life Sciences, discussed the topic of adding risk-based controls to a learning program. First she described how risk-based approaches are reshaping compliance learning. She indicated that in 2011, some of the most cited quality unit topics in Warning Letters for Pharma included such items as:

1. “QU failed to establish a system to ensure that…”
2. “QU failed to document the responsibilities applicable to the quality control unit in procedures, and fully perform these responsibilities.”
3. “The personnel performing laboratory tests… were not trained.”

She indicated that for medical device manufacturers, the Warning Letters included:

• CAPA- Corrective and Preventive Actions
• Design Controls
• Production and Process Controls
• Management Responsibility

Then she offered Three Best Practices for Taking a Risk-Based Approach to Learning. She provided the following:

Best Practice #1: Align Training to Audit Findings—Scour internal and external audits to identify any trends related to inadequate performance by employees based on departments,   subject matter, compliance requirements, facility, job function or even production line. Identify the root cause of the performance failures; confusing or out-of-date training materials, incorrect distribution, lack of comprehension, “training overload.”  Once scoured, align the training to the audit findings.

Best Practice #2: Automating the Assessment to Deliver Targeted Training—Use the functionality of Smart Forms to enable compliance and QA managers to translate “high-risk” matrix into compliance programs to ensure training activities are delivered to proper learners. Make sure you automate the workflow of capturing learner’s pre-existing knowledge for placement into high-risk groups and use rules to form questions so that a specific response adds the learner to a “high risk” user group, or remove the learner from a user group.

Best Practice #3: Mitigating Third Party Risks—Find tools that automate third party training and deliver management visibility and provide a flexible way to designate sponsors within your organization who “own” the third party relationship. Also automate training and e-mail notifications to third-party individuals and enable individuals to maintain their own profiles.

Great information was provided and many good ideas were exchanged and discussed.

How do you transfer knowledge and best practices within your own company?

Note: This is part of a blog series on the 2012 Knowledge Summit.

The first presentation of the Knowledge Summit was the Keynote presentation by Carla O’Dell, Ph.D. The title of her talk was The New Edge in Knowledge: How Knowledge Management is Changing the Way We Do Business.  Carla is the author of the book The New Edge in Knowledge.  She started her presentation with a story describing how people often know knowledge but fail to transfer that knowledge effectively. She then asked the poignant question:  “Within organizations, why don’t people transfer best practices even when they know about those best practices? Why don’t they implement known best practices?”

Carla’s presentation discussed three areas:

• Demystify Knowledge
• Explore How to Transfer It
• Share Rules of Thumb

She explained that the nature of knowledge is that it is intangible (if I drop it on my foot, it doesn’t hurt). Knowledge is created based on direct personal experience, it comes from within. However, she cautioned, the impact of knowledge is tangible.  Another advantage of knowledge is that it is not depleted by sharing. In fact, it can grow by sharing.

She indicated that people seem to be hard-wired to share knowledge. If that is the case, she stated, why is it so hard in organizations? She indicated several reasons why organizations have trouble sharing knowledge.

She pointed out four reasons why people don’t share knowledge. The reasons are:

1. Types of Knowledge-Explicit knowledge is easier to share but not as valuable as tacit knowledge.
2. Nature of organizations -Organizations tend to lack  at sharing.
3. Multiple Generations at Work- Different generations have different methods of sharing and receiving knowledge.
4. Expecting knowledge to go viral-Most knowledge within an organization will never go viral.

Carla, made the point that knowledge is sticky, without a systematic process and supportive environment, it won’t move, it needs a process to move.

She indicated that the three most approaches for dissemination of knowledge.

1. Create and disseminate a best known method-top down.  This is when the cost of not knowing is too high.
2. Networks and communities of practice as the vehicle for transfer. Networks are great for the dissemination of knowledge within and outside of organizations.
3. Facilitated site to site transfer. This is the most effective but most expensive.

 

First set of Client Awards

Following  Carla’s presentation, three clients were presented with awards.

Winner in Compliance —The Lifetime Healthcare Companies. Accepted by Sandra Force, Susan Garand and Timothy JX Hill. This team described how they deployed a Conflict of Interest Course and the evolution of the way the course was delivered over the years from a paper-based process all the way to using UL EduNeering’s Form Monitor functionality.

Winner in Innovation—DPT Laboratories. Accepted by Brian  L. Krenc.  Brian described how he used Smart Forms and Customer Reports to gather the data he needed to drive compleons for annual GMP Training. He described how the LMS gave him greater oversight and real-time information on progress for all locations within the organization including Curacao.

Winner in Operational Excellence—Johnson & Johnson Health Care Compliance & Privacy. Maria M. Pérez accepted the award.  Maria explained how they worked to create an implementation of a global instance of the LMS using SSO/SAML to allow 190,000+ users simplified access to the system.  The process included creating multilingual navigation setting preferences in 34 languages and a third party self-registration process along with simplified password retrieval.

The day was capped off with a wonderful trip to the National Aquarium.

2012 Knowledge Summit Recap Opening Remarks

Note: This is part of a blog series on the 2012 Knowledge Summit.

This year’s UL Eduneering Knowledge Summit was a huge success.The annual event had over 120 attendees from various industries across UL EduNeering’s client base. The summit created an energetic atmosphere where ideas, concepts and knowledge were freely exchanged, discussed and examined.  A good time was had by all.

The meeting included a presentation by Patrick Boyle who presented on why UL EduNeering is an ideal fit for the UL organization. He explained UL’s expansion from its traditional role in product safety related to electricity to include “Safe Working and Living Environments for People”.  UL EduNeering’s mission to provide “assurance to the management of our client organizations that their employees develop the necessary knowledge to perform their work activities in compliance with ever-changing regulatory requirements and in conformance with internal policies and procedures” fits well with UL’s focus on safety. The shared goal of safe people, safe environments and safe organizations prove to be a strong combination.

Patrick Boyle also discussed the UL Business Units and indicated that Eduneering fits under the business unit of “Knowledge Services.” The units are:

• Product Safety-Encompasses UL’s traditional testing and certification business; helping manufacturers bring safer products to markets faster.
• Verification Services-Provides performance / verification testing and inspection services for manufacturers and retailers
• Life & Health-Focuses on human safety in the medical, food, and water industries
• Knowledge Services-Offers training, education, and technical expertise in product safety and related areas
• Environment-Provides environmental claims validation and certification to help guide industries, governments, and consumers with sustainability and environmental product-related decisions

After Patrick Boyle’s presentation, Lisa Clune, President of UL EduNeering took the stage and discussed “numbers.” She provided a series of numbers and explained their significance to UL EduNeering. Here are some of the numbers and their associated meaning:

• 3—Number of years in a row Eduneering has won the “Best Advance in Learning Management Technology for Compliance Training” award.  These awards are presented by Brandon Hall Research, one of the leading research firms in training and development. The Excellence in Technology Awards program showcases innovative products in the marketplace for creating and managing learning, talent and performance.
• 53—Number of new clients UL EduNeering has acquired in 2011. Lisa stated that this number indicates that the “solutions EduNeering creates are relevant to the market place”  and that UL Eduneering continues to deliver on the needs of the market place. Already this year, 2012, 25 new clients have been signed. A pace well ahead of last year.
• 1.5 million—Number of active users on EduNeering Learning Management Systems.
•  22 millions—Number of completions on the system in 2011, up 39% from the year before.
• 34-Number of languages currently available for the Eduneering platform.

Lisa Clune ended her presentation with the top five reasons why she is excited about the Eduneering/UL relationship.

1. Entrenched in certification, inspection and the audit process.
2. Deep medical  device expertise
3. New OSHA- approved solutions from  sister company UL Pure Safety
4. Global footprint
5. Mission is all about product safety.

With UL’s recent acquisition of EduNeering, UL now has one of the largest compliance and safety related training library in the world with over 2200 courses. Everyone was excited about the announcement of Eduneering becoming an integral part of the UL brand.

 

Busting Learning Myths: Fact or Fishy

This tour stop is related to the presentation and book signing at the UL EduNeering Knowledge Summit. It was a lot of fun and as always a fantastic event. This year I provided a presentation about busting learning myths. We did this by playing a game called “Fact or Fishy” and we used Poll Everywhere to gather audience input.

The audience voted on whether or not a statement was true “fact” or false “fishy”.  Since we had dinner the night before at the Baltimore Aquarium, it seemed appropriate.

Here are the recommendations from the session on learning and the research references to back them up for those of you who may be curious.

1)     Craft instruction to provide opportunities to increase engagement and interactivity to increase learning. Engagement leads to learning add activities and exercises that increase engagement. Research shows that engagement is what makes games educational, not competition or points.

Source: Sitzmann, T. (2011) A meta-analytic examination of the instructional effectiveness of computer-based simulation games. Personnel Psychology .Review of 65 studies

2)     When teaching a process, teach system components before teaching the entire process. Teach each component individually, then the learner will be prepared to assimilate the stages of the entire process. Otherwise you risk overloading the learner’s memory by presenting everything all at once.

Source: Clark, R., Nguyen, F. & Sweller, J. (2006) Efficiency in Learning: Evidence-Based Guidelines to Manage Cognitive Load. New York: Pfeiffer. Pg. 162-165.

3)     Animations are not always the best tools for teaching concepts. Static images tend to work better in training. A number of studies have failed to find that animations are more effective than a series of static frames depicting the same material. Why? Learners have to mentally animate content in still graphics. Learners control pace and speed of information presented. Memory is not overloaded by rich detail and transitory nature of presentation.

Source: Clark, R., Mayer, R. (2011) E-Learning and the Science of Instruction: Proven Guidelines for Consumers and Designers of Multimedia Learning. New York: Pfeiffer. Pg. 84-86.

4)     The tone of e-learning should be conversational. In 5 out of 5 studies, learners who learned with conversational text performed better on subsequent transfer tests than students who learned with formal text. Learners produced between 20 to 46 percent more solutions to transfer problems than the formal group.

Source: Clark, R., Mayer, R. (2011) E-Learning and the Science of Instruction: Proven Guidelines for Consumers and Designers of Multimedia Learning. New York: Pfeiffer. Pg. 184-185.

5)     On screen characters can enhance e-learning. On transfer tests involving different word problems, the group who had a character generated 30% more correct answers than the group with on-screen text. Animated pedagogical agents (characters) can be aids to learning.  A “realistic” character did not facilitate learning any better than a “cartoon-like” character.

Source: Baylor, A. L. & Kim, Y. (2005). Simulating instructional roles through pedagogical agents. International Journal of Artificial Intelligence in Education, 15(1), 95-115. And Clark, R., Mayer, R. (2011) E-Learning and the Science of Instruction: Proven Guidelines for Consumers and Designers of Multimedia Learning. New York: Pfeiffer. Pg. 194.

6)     Two on screen characters (mentor and expert) are better than one. It is ideal to have one onscreen character providing information and content and another onscreen character providing coaching and motivation. Learners seem to be better able to parse the information from two different characters.

Source: Baylor, A. L. & Kim, Y. (2005). Simulating instructional roles through pedagogical agents. International Journal of Artificial Intelligence in Education, 15(1), 95-115.

7)     When a graphic is the focus of instruction, words should be spoken rather than presented as text. Learners may experience an overload of their visual/ pictorial channel when they must simultaneously process graphics and the printed words that refer to them. When visuals are relatively complex, using audio allows the learner to focus on the visual while listening to the explanation.

Source: Clark, R., Mayer, R. (2011) E-Learning and the Science of Instruction: Proven Guidelines for Consumers and Designers of Multimedia Learning. New York: Pfeiffer. Pg. 117.

8)     Use stories rather than bulleted lists to present facts to learners. Researchers have found that the human brain has a natural affinity for narrative construction. People tend to remember facts more accurately if they encounter them in a story rather than in a list when training.

Source: Carey, B. (2007) This is Your Life (and How You Tell it). The New York Times. http://www.nytimes.com/2007/05/22/health/psychology/22narr.html?pagewanted=all And Melanie Green http://www.unc.edu/~mcgreen/research.html

9)     Present learners with a difficult challenge so as to engage and motivate them. People are motivated to overcome challenges. Include a challenge in your instructional design.

Source: Jones, B., Valdez, G., Norakowski, J., & Rasmussen, C. (1994). Designing learning and technology for educational reform. North Central Regional  Educational Laboratory. [Online]. Available: http://www.ncrtec.org/capacity/profile/profwww.htm  and Schlechty, P. C. (1997). Inventing better schools: An action plan for educational reform. San Francisco, CA: Jossey-Bass

10)  Games can influence people to behave in a pro-social manner. Several studies have shown that after people play “pro-social games” where they do something nice for someone, that behavior translates outside of the game in behaviors and activities.

Source: Greitemeyer, T. & Osswald, S. (2010) Effective of Prosocial games on prosocial behavior. Journal of Personality and Social Psychology.  Vol. 98 . No. 2., 211-221

 

If you are interested in viewing the presentation please follow the link below:

http://www.slideshare.net/kkapp/busting-learning-myths-fact-of-fishy

Knowledge Summit 2012: Using Knowledge to Manage Risk

Every year UL EduNeering facilitates a fascinating discussion among clients, industry experts and UL EduNeering employees in the venue known as The UL EduNeering Knowledge Summit. The idea of the UL EduNeering Knowledge Summit is to create an atmosphere where ideas, concepts and knowledge are freely exchanged, discussed and examined. Having attended almost all of the UL EduNeering Knowledge Summits, I know attendees are going to in for a real treat.

This year the speaker lineup includes Dr. Carla O’Dell, who is a guru in using knowledge for competitive advantage and is the author of the book The New Edge in Knowledge: How Knowledge Management Is Changing the Way We Do Business . She will be providing lively interactive exercises and thought provoking content regarding the concept of knowledge. She will discuss how to retain knowledge, how to leverage it and how to protect it.

Also, Newsweek Technology Editor Dan Lyons will offer a humorous, insightful, and somewhat cynical take on the grand bargain we are making as we enter the age of the social Internet. His talk is titled ZUCKERBERG'S PANOPTICON: The Rise of Social Internet and the End of Privacy as We Know It and he explores how Social Web sites like Facebook are radically transforming our notion of privacy. He will address questions like: How do we deal with a world in which our personal information has been turned into a form of currency, and used to pay for online services? How do we know whether we're getting a good deal?

The discussion by Dr. Karl Kapp (me) will focus on the evolving training matrix and how new technologies and social media fit into the mix.  I will weave a tale of how technology is creating unparalleled opportunities for transferring knowledge, directing behavior and generating innovative ideas. The talk will explore the uses of virtual worlds, social media, game-like interfaces and digital storytelling to compel learners to action.  I will also talk about my latest book The Gamification of Learning and Instruction. Additionally, EduNeering’s Chief Learning Officer, Carrie McKeague, will provide demonstrations of exciting new interactive exercises being added to UL EduNeering courses as she and I discuss interactive learning elements and gather audience input.

Of course, some of the most interesting and insightful conversations will arise from the client presentations as clients receive The Knowledge Summit Achievement Awards. These awards acknowledge the great contributions UL EduNeering clients make to the field of compliance and learning. These will be some of the most interesting discussions of the 2 day events, where the award winning clients share their ideas, thoughts and best practices.

Of course there will be book signings, networking opportunities, a progressive dinner at the National Aquarium and an open and free exchange of ideas. Plus, you’ll gain some insights into what UL EduNeering is doing in terms of creating new products and learning tools.

There will be an insightful line up of speakers for a chance to take a break from the usual work-a-day discussions and contemplate how knowledge impacts your job, how the internet impacts your life and how technology will change your at-home and at-work future in foreseeable and unforeseeable ways.

Follow us on Twitter to interact with us during our Summit and to keep up the conversations join our LinkedIn group as we will be exploring additional items that arise at the UL EduNeering Knowledge Summit!

Are you ready for a custom e-learning course?

In a prior post, I defined Custom e-learning courses as courses developed for a particular client and audience on a content area focused on specific learning needs. These courses are “made to order courses” and with each level of specificity comes increased development time, a commitment for your internal resources, and costs.  

However, before dedicating time, effort and costs, we would like to suggest that you use our Custom Course Readiness Self-Assessment form to evaluate your readiness for a Custom e-learning project. Consider your answers and then sum your scores.  With your overall number use the guide to gauge your readiness.

5 = Strongly agree  
4 = Agree
3 = Partly agree
2 = Disagree
1 = Strongly disagree

 

Readiness items	Score
Needs Analysis:  You have identified the potential course subject as a “high-risk” topic that impacts your organization’s business from a compliance or performance perspective.
Course Objectives:  You have identified either problems or opportunities (such as a new product or process) that you want to address in the course, especially as it relates to your audiences.
Learner Knowledge:  You have identified specific skills or knowledge that learners will need to acquire through the course.
Subject Matter Expert:  You have identified a Subject Matter Expert (SME) who can approve and/or provide resources for the instruction.
Course Content:  With the help of the SME, you have identified what the learner needs to know to accomplish each step as part of the process or procedure.
Course Changes:  You don’t expect the course content to change frequently (e.g., more than twice a year?)
Course within Your Learning Program:  You have determined that the course will serve one of two purposes:  1) as a prerequisite within a series of learning activities (which include additional computer-based courses or classroom training, or 2) as a stand-alone learning resource focusing on a critical topic (Code of Conduct, a single SOP, etc.)
Learning Infrastructure:  You have checked your learning management system to ensure it can support the delivery and management of the course (e.g., LMS is SCORM compliant).
Course Delivery:  You have confirmed that your learners connect to the course via the Internet from a dedicated PC or computer training room within your organization.
Course Measurement:  After the course is launched, you have a plan to measure learner performance, to identify whether the content and design were appropriate for the learners.
Total Score

If Your Total Score Is . .

Between 40 and 50:  Your firm has clearly defined the goal of the custom course, and you have considered the course topic, your audience and the delivery of the course to these learners.  Based on your answers, and our experience in custom course development, we believe you should proceed with your custom course project. 

Between 30 and 40:  You may need to review your lower score questions to identify potential risk areas that may compromise the success of the course launch.  For example, you may not have defined the existing knowledge level of your learners, and by taking the steps to acquire this information, you can focus the course content on areas that will foster behavior change in your learners. 

Below 30:  You may want to evaluate your course readiness before moving forward with your custom course project.  By reviewing the steps outlined in the ten best practices, you can gain assurance that the final custom course will meet your business and/or compliance objectives.

Three More Ideas for Improving the Delivery of Synchronous Learning Programs Part 2/2

A little while ago, I penned a blog entry titled “Three Ideas for Improving the Delivery of Synchronous Learning Programs.” The post was based on EduNeering’s 2011 ComplianceWire Benchmarking Study that found that organizations were “conducting more synchronous (instructor-led) web-based activities.” Here are three additional ideas:

1. Liberally Use Graphics. When designing the slides for your session, include both words and large and appealing graphics on the screen rather than worlds alone. Providing one bulleted list of points after another is an ineffective way to display content and can quickly bore the attendees. There is a large body of evidence that supports the concept that people learn more from words and pictures than from words alone. Consider adding visuals to the content you are presenting so that you have both words and visuals on the screen.
2. Let the Learner’s Take Over. Provide opportunities for learners to interact on the whiteboard. Create a  list and have learners place a check mark by items, have them circle areas on a production line that are not in compliance, give them the drawing tools and allow them to interact. Synchronous learning can become synchronous lecturing if one is not careful. Take advantage of the breakout tools and put learners into groups to discuss and issue and then have them reassemble. Whatever you can do to encourage interaction, engagement and energy in the session is going to lead to more learning. The more engaged a person is in the learning process, the more they are going to learn.
3. Think Like National Public Radio. When planning and designing a synchronous learning session, don’t think of it like a classroom lecture. Think of it like radio piece for NPR. When they craft a radio story they provide engaging ambient sounds as a lead in, they use snippets from interviews, they paint a mental picture in the mind of listener. Do the same. Use royalty free music and sounds to “set up” your lesson. Provide snippets of interviews with experts about the topic you are covering. Strive to paint a mental picture of what you want the learners to do after your instructional session. You are not just delivering a synchronous lesson, you are giving a performance.

UL Acquires EduNeering Online Compliance Training

On April 9, 2012, Kaplan EduNeering was acquired by Underwriters Laboratories (UL).

Official press announcement here.

With the acquisition of EduNeering, UL has broadened its regulatory and compliance solution for the Life and Health Science sectors. EduNeering's award-winning solution enables compliance, risk mitigation, workflow automation and improved business performance for FDA-regulated organizations.

EduNeering will now operate as UL EduNeering within the UL Knowledge Services business unit. As part of UL's global network, this new partnership will be able to offer organizations access to a wider breadth of learning and knowledge services.

Our 700+ off-the-shelf library, including FDA authored and AdvaMed approved online courses, remains available in addition to expanded libraries in the following areas:

• energy operations;
• manufacturing;
• ethics;
• environmental health and safety;
• food safety.

UL is the premier global independent safety company, relied upon for building trust in the global marketplace. For more than 117 years, UL has conscientiously advanced safety science, instilling unmatched trust and confidence with over 23 Billion products bearing the UL certification mark.

Official press announcement here.

3 Reasons for Compliance Training

Occasionally people will moan and groan about the need to take compliance training. They’ll complain that they are too busy or that they already know the content or that it’s just common sense. They are, for whatever reason, above the need for such training. Here are three reasons why those arguments are bogus.

1. Humans learn through repetition. Remember trying to learn multiplication tables, it is not a one-and-done proposition. Few people can review those complicated tables once and know immediately that 5 x 9 = 45. So why do people think they can review complicated compliance regulations one time and know all there is to know for the rest of their lives? Why do they think that once they took a compliance course, they never have to take another? Not realistic and not sound from a learning perspective.  Compliance, like other human endeavors, requires a constant refresher to ensure that it is top-of-mind and to allow the learner to mentally rehearse the nuance of regulations and adherence to those regulations. Taking a compliance course at regular intervals provides the needed repetition to ensure that the knowledge is deeply encoded into the minds of employees.
2. Humans learn through reflection. In the busy hustle and bustle of a work day there is little time for reflection. Things happen too quickly and stopping and reflecting on practices and procedures is typically not very high on the priority list. Training opportunities give people the chance to slow down and think about things. As a person is moving through compliance training, they have the chance to reflect on their own practices and the practices of co-workers. They have the opportunity to deeply think about their actions and activities and how those support or do not support compliance. Training should not be seen as an inconvenience, instead, it should be thought of as an opportunity for reflection.  Encourage trainee’s to recast compliance training as reflection time—a time to think about how they and their co-workers are doing in terms of compliance.
3. Humans learn through from others. No person is an island and no one is born knowing everything. We learn from others. Training is the perfect opportunity to learn from compliance experts and others with whom we may never have a chance to meet. Compliance training takes the expertise of key employees, compliance experts from the field and other notable individuals and makes that information available to everybody. It takes the old one-to-one apprentice to master model and scales the model. Now any employee can learn from experts simply by engaging in the training model. Compliance training provides access to experts at your own pace at your own direction. They won’t talk too fast or move too quickly in an online module. You, the learner, have complete control. You learn from the best through the module.

So the next time someone gives you a lame excuse for not wanting to take a compliance course, give them one of these responses, you’ll open their mind to the tremendous benefit of compliance training for both the organization and the individual.

Complaint Management Best Practices Discussed at AdvaMed MTLI

Last week I was fortunate to attend the two-day AdvaMed MTLI Medical Device Complaints and MDR meeting in Washington, DC. The event was extremely informative and included two FDA officials, who presented details about current regulations.  

For me, frankly, it was a humbling experience.  

While I have basic knowledge of adverse event regulations (thanks to our own FDA-authored MDR and QSR courses), I was amazed at the myriad of complaint management issues facing quality and regulatory teams: field investigations, trending analysis, risk assessments, call center operations, recall strategies, and more.  

When the issue of training was raised, I felt a little bit more in my comfort zone. Many medical device clients use our ComplianceWire LMS to train employees on complaint submissions and related topics. During the event, presenters and attendees delivered a number of training best practices, such as:

1. Include “Handling Adverse Events” as part of the employee on-boarding process;

2. Provide different levels of training for client-facing employees (Sales and service) versus all other employees;

3. Go beyond the basic SOP” by including real-life situations and examples;

4. Make the SOP easy to understand; remove the jargon, if possible;

5. Provide basic inquiry questions so that submitters can provide facts, rather than generalizations or hyperbole.

A key take-away from the meeting was this: because complaint files are reviewed by FDA and other regulatory agencies, having employees provide “context” with a complaint submission can ultimately shape the inspector’s perception of your system. For ComplianceWire clients, this means delivering the “complaint handling” SOP along with an assessment, training aids, decision trees, and other materials, all contained within a “Complaint Handling” qualification. Further, clients can take advantage of ComplianceWire’s role-based features to tailor training for various groups in the organization. They can develop a more process-intensive curriculum for the complaint handling team, while including field scenarios in the curriculum for sales and service personnel.

For that reason, we developed a 45-minute online course, “Reporting Adverse Events for Medical Devices” that introduces sales and service personnel to FDA’s MDR process and identify the reporting types. Clients can include this course into a blended “complaint handling” curriculum that includes internal procedures and classroom sessions. Like all of our courses, this course includes mastery-based learning activities that really fosters retention, so they can take the lessons into their everyday business activities. Let us know if we can share other best practices you have found that work best.