Tag Archives: compliance

Fun Compliance Training – A Real Phrase

Fun Compliance Training – A Real Phrase

Fun Compliance Training – A Real Phrase

Fun Compliance Training – A Real Phrase

In life, there are few certainties, one in particular which you will be exposed and subjected to is compliance training. It is not everyone’s favorite and with good reason. Compliance training as we know it is meant to be a boring and highly regimented experience. But as many before me and many after me have pointed out, it does not have to be. Believe it or not, compliance training as we know it is slowly evolving. People understand the dry sentiment that they are providing to their workforce and are focusing on techniques in which they can improve delivery, effectiveness, and user attention. Now, with that being said, some compliance training needs to remain a serious ordeal, as it may be irresponsible to portray the solemn hazards of nail guns, radiation, forklifts, and other potentially dangerous exposures in the methods in which I am going to be suggesting below.  

Add Humor

Funny Sells. Think back to all of your favorite Super Bowl commercials over the past few years. It may all seem a blur, but the bits and pieces you can piece together are either the ones that weave strong storylines in 30 seconds or the ones that were funny enough to cause you to spit out a little bit of your beverage. The same concepts can be applied to Compliance Training. Workplace safety is no joke and should be portrayed in a serious manner. However, components of workplace training are already funny within themselves. Remember, the reason there are rules and behaviors we need to implement, is because someone has actually done some of this stuff, not only in your organization but on a global level. Do not be afraid to call out the humor in common sense practices, and verbalize the humorous natures of some of the experiences you yourself have undergone. This practice will go a long way in extending the message you are attempting to portray to your personnel, as a few laughs here and there could be all you need in order to keep the focus of the individuals undergoing the training. It is worth mentioning that there is a very fine line of acceptability here, as it is very important not to eclipse the severity of the topic in which the staff is being trained on.

Use Storylines

As the other component of the Super Bowl example, stories can be equally important to furthering the retention of the messages you are attempting to convey. Be sure when implementing this method that you structure a believable storyline, develop characters, and incorporate real-life scenarios. The course message can be conveyed more effectively if the people undergoing the learnings can identify with the storyline they are presenting. This can best be achieved through the understanding of the class breakdown and through the establishment an underlying course strategy. These stories can be further augmented with the inclusion of participation. Choose your own outcome books have been commonplace in bookstores for years. Why not preface the group with some specific examples allowing them to see the downfalls of their chosen pathway. When importing the concept into your Compliance Training it is imperative that the employees can see for themselves both the hazards of selecting the wrong outcome, as well as the success of maintaining compliance.

Clearly Defined Rules

It is important when implementing these methodologies to not lose sight of the purpose of the compliance training. There are specific rules, guidelines, and regulations that need to be conveyed to the participants. Humor and storyline serve merely as a vehicle to better deliver this content and above all, these norms are the true reason for the training. A clear focus on the required outcome of the compliance training can lead to a better picture of the true necessary components of what is being presented. Understanding the interworking of the course can go a long way towards structuring a concise offering that is best received by the employees undergoing the courses.

Shortened Course structure

A lot of programs have migrated instructor-led compliance training over to e-learnings, which as a format can easily contain the components suggested above. The nature of this format itself is a bit more conducive to a shorter program emphasis. If a compliance training e-learning seems a little long, consider breaking it up into micro learnings which can serve the purpose of further conveying the message of the training itself and aid in the retention of the course. Be sure to take advantage of all of the available mediums, not using them for the sake of using them; but instead utilizing video, audio, games, and etc. when appropriate to further the impact of the content.

When devising a compliance training program, have fun with it. If you go into the process thinking that it is a boring, regimented, and necessary evil that your employees must undergo, then that is how they will view the offerings. Be sure to consider adding comedic elements, structuring stories that are relatable to the workforce as opposed to just listing the compliance factors as what they are, while carefully focusing on the rules and regulations you are attempting to portray onto the class itself. To add some icing on the cake, compliance training does not need to be an all-day event, be sure to consider the implementation of micro-learnings to further the ultimate reach of the courses. I hope you have enjoyed this post and continue to join us here at the Gyrus Blog as we discuss all topics pertinent to the learning industry.

21 CFR Part 11 FDA Compliance: What Your LMS should provide?

21 CFR Part 11 FDA Compliance- Electronic Record Electronic Signature

Organizations are finding new, faster ways to deliver real-time training, e-learning and are leaving behind instructor-led training practices. Learning Management Systems (LMS) are the key to deliver unified, effective and controlled training programs.

For food, pharmaceutical and clinical companies, LMS can also achieve 21 CFR Part 11 compliance. 21 CFR Part 11 establishes the standard by which the U.S. Food and Drug Administration (FDA) considers electronic signatures, records, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

These organizations face significant risks if found non-compliant. They may receive a Form 483(A list of observations made during the inspection that is communicated at the conclusion of the inspection), a Warning Letter, or even a consent decree impacting their time-to market, productions, brand reputation, etc.

Finding a LMS provider with basic features and capabilities is an easy task as long as you know your training requirements. However, selecting a provider that understands the FDA criteria for electronic records authenticity requires an in-depth study of provider’s capability and expertise.

Let’s look at some key features that you must avail through your LMS provider to ensure you are 21 CFR Part 11 compliant:

Data Access and User Authentication Process: A LMS should provide a robust user authentication through strong username and passwords, automatic password expiry and verified password recovery process. User accounts should not be shared, and one user id should apply to only one person. For Single Sign On (SSO) process API authentication should be enabled. It is important that the LMS provides a robust data access structure to control a user’s access and functions based on various parameters.  See if they have access control checks and form validations to ensure only valid data entry and the user is authorized to perform the action. The system should also ensure that only authorized individuals can electronically sign a record or alter a record.

Audit Trail Access: You need to evaluate how much manual work versus customized reports is available when you are looking for a particular data. For Example, if the audit trail is for a particular training course applicable to a particular location, can you filter the results easily? Also, find out what kinds of data points are required to be audited for each fields and whether there are workarounds if certain data points are not present.

Report Generation for Inspection: The LMS should have ability to generate accurate and complete copies of repots both in printable and electronic format for review and inspection purposes. See if these report can be customized based on particular search parameters. Quick and easy to access report allows organizations to be inspection-ready more effectively; it also allows them to appropriately limit the data you present to the FDA during an audit. The organizations also need to check if reports are configurable to ensure that they meet their future reporting requirements.

It is extremely important that organizations partner with a LMS vendor that have prior experience working with regulated companies. A right LMS helps pharmaceuticals and clinical organizations to automate and manage their training initiatives while conforming to regulatory requirements, including 21 CFR Part 11.

Are You Compliance Ready?

Compliance blogCompliance training ensures that employees, contractors, and partners have the right knowledge and understanding to comply with an organization’s legal, operational, ethical aspects of business. It is something that organizations can’t compromise on, if they don’t want to risk a complete business failure.

Despite regular reiteration of all state and federal compliance guidelines and audits, organizations fail to be compliant with the latest regulations and research indicates that compliance lawsuits have increased tremendously over the past few years.  A recent example is of Barclays Capital Inc., who was charged by The U.S. Securities and Exchange Commission for failing to build adequate compliance systems, after the firm acquired Lehman Brothers' advisory business in 2008. It resulted in overcharges and client losses of $472,000, for Barclays.

Even companies who have a proper compliance methodology get caught in the midst of changing regulated environment, new compliance measures, etc. At times, they focus on one area of a compliance program more while sidelining other elements. Or, they are still following the outdated compliance policies and technology at the organization.

Let’s look at ways through which organizations can develop a compliance culture and be prepared for compliance audits.

Leadership Focus: If the leaders own and support ethical, compliance measures, it is going to trickle down in the organization in the same way. Senior executives should be the role models for employees to build a strong compliance culture at every level of an organization. It is important to show and communicate that leaders are committed to compliance measures and the company will not negotiate on its compliance program in any way.

Identification of Risk Areas: It is important for organization to identify and evaluate all risk areas that relate to its core business. They also need to identify and abide by workforce rights and regulations pertinent to them to save themselves from an employment lawsuit. Organizations must create a complete checklist of risk areas to create the right compliance strategies and measures. It is also important to evaluate them in order to put the right focus on different areas.

Communication and Training: Compliance policies and regulations must be effectively communicated to employees along with the right training and technology. Organizations should ensure that there is a proper communication between the compliance team and employees. Training should be done in a systematic, centralized and seamless way with a proper reporting and monitoring structure. If there is a need to customize the training courses for different functions at the organization, the compliance team should be ready to provide that.

Review and Monitoring: A compliance program should be reviewed on a recurring basis to catch any breaches or potential lapses. Regular review and monitoring would provide an opportunity to discover compliance failures, issues before it becomes uncontrollable. The compliance team should work along with the leadership team to take the right measures to stop such lapses take place in future. A regular report to leadership team also ensures their ongoing attention and commitment for compliance programs. A compliance training report can also act as a proof during a compliance audit.

To build a robust compliance program, it is necessary to invest in to the right technology, processes and systems. Organizations should look for a Learning Management Systems (LMS), which can help them communicate, monitor as well as report on their compliance programs. A LMS will also help in automation of certain processes, which will avoid lapses and manual failures.

The Benefits of a LMS For Government Organizations

While T&D is important for all industries, there is a lot of emphasis placed on T&D  in government organizations. In current times it is absolutely critical for government agencies and organizations to respond quickly to constant challenges and to be trained and competent in order to face them. Training of federal, state and local employees can be easily managed through a learning management system. With the right amount of user learning functions and capabilities, adopting this software can provide a high return on investment (or ROI) and overall workplace development.

A learning management product is perfect for any government organization because it reduces costs and time for a T&D initiative, leading to increased productivity. It also helps organizations remain compliant. Your organization is constantly growing, so you’ll want to choose software that is scalable and can grow with you. The ideal vendor for government agencies will understand the regulatory and compliance needs of government agencies, and especially focus on compliance, safety, security, and T&D. It’s also important that reporting is available within the learning management system to help you track progress and history in an organized manner without paper or spreadsheets.

Since training is so important in the government industry, organizations should make wise decisions on which learning management system and vendor they choose. For example, Gyrus Systems is a government approved vendor and their GyrusAim product can be integrated with OPM’s Enterprise Human Resource Integration system (EHRI). The GyrusAim software can also create, store, manage, and transmit SF-182 requests and is compliant with Section 508 of the United States Workforce Rehabilitation Act of 1973.

Safety and security are critical factors of government agencies, which is why GyrusAim is a very secure platform for data, and customers also have the option to self-host their software. Because GyrusAim is a web-based software, it can be accessed by learners from anywhere at their convenience, and can be translated into over 25 languages. Our federal, state, and local government clients are guaranteed the lowest rate available.

Our government clients expect nothing but the best and we strive to deliver that. We understand the difficulties in dealing with the proceedings that go along with acquiring a vendor and maintaining a relationship with that vendor, therefore we are proud to be a General Services Administration (GSA) vendor. We have over a dozen government clients and are familiar with their individual needs. Our learning management system also caters to non-GSA government clients and we are prepared to offer you a learning management system that is customizable to your needs and goals.

 

 

 

Three Reasons Why Tracking Training Should Be Your Top Priority

Got training? Prove it. One of the most important factors in T&D is tracking your company’s programs. Who is certified? When is programs are conducted? What is required and what is optional? Keeping track will not only keep your business up and running (legally), but will lead you to further success because it will allow you to create the most effective program possible. Below are three reasons why tracking students is important:

1. Compliance

Without laws, industry standards, and regulations, training would not be the same. Don’t risk legal action by forgetting to track all of the programs that are going on. Human rights and health and safety are two main compliance categories where T&D is pertinent. But simply conducting the it is not enough—you must track it and therefore be able to prove that your company is compliant and up-to-date.

2. Productivity

By tracking learning, you can discover patterns in the productivity of your workplace. Do performance levels start to diminish after a certain amount of time? Are there more mistakes made after a worker has been with the company for a certain amount of years? A program could be the perfect solution to boost performance and refresh the employee’s knowledge. It can also provide employees with the motivation to succeed and excel in your organization.

3. Record keeping

Referencing back to reason number one (compliance), many laws require you to have documentation of your efforts, such as health and safety requirements. Certifications are also important to keep on record, such as in the healthcare industry. Offering T&D opportunity is simply not enough in today’s day and age, you must also be able to prove that opportunities are being offered and employees are participating regularly as needed. Referencing reason number two (productivity), record keeping can also help you discover which records are effective and helpful, and which ones do not yield as significant results (ILT versus eLearning).

You’ll also need to get rid of your spreadsheets, file folders and paperwork (we think you’ll be more than happy to see them go). If you’re conducting ILT or eLearning, we suggest keeping it organized in a learning management system, such as GyrusAim. Various reporting and certification functions will allow you to manage and track records and employee progress without having to replace any ink cartridges or fix paper jams (again, something we highly doubt you’ll miss dealing with).

So you’re ready to select Learning Management System

So, you’re convinced it’s finally time to select a real Learning Management System. What was the straw that broke the camel’s back? Was it the latest mandate to develop standardized learning programs company wide? Or is it this year’s directive to incorporate succession planning, career development and pay more attention to employees outside the United States?

Maybe your company is much smaller than the corporate giants with an international presence and it’s just about getting everyone who has a hand in employee development on the same page? Duplicate Excel spreadsheets, new elearning initiatives, redundant training development, managing no-shows, empty seats, training schedules via multiple emails, compiling reports that take hours only to be asked to recreate similar reports at management’s whim each month?

Where do you begin to research vendors and understand the scope of implementing an LMS? How long should the implementation take? Does IT need to be involved up front or should you narrow down your search before putting in a request? What type of services do vendors offer? How much or how little can you do yourself?

These and many, many other questions are fair game for anyone taking the LMS plunge. From the vendor perspective, we want to help you through the research and evaluation process and we want to help set the right expectations. Ultimately, it’s your success that makes us a success.

There are several free resources available for LMS researchers. I recommend this free digital ebook, 339 Tips on LMS/LCMS Implementations, published by the eLearning Guild. Implementing a Learning Management System with the right expectations can make all the difference in your success. Armed with the right tools, you can make a difference in establishing an effective workforce development program.