If you are a medical device manufacturer, you already understand the substantial role regulations and regulatory agencies play in your business. In particular, the FDA’s 21 CFR Part 11 standard.
The FDA audit is one of the most anxiety-producing prospects for medical device manufacturers, and for many manufacturers, it is also the most challenging part of their industry.
When you are placed on the FDA’s watch list or cited with a Form 483, it significantly impacts how you do business, and potential investors and customers see your company.
Rather than dealing with the aftermath of a failed audit, medical device manufacturers should put in place certain measures to ensure they can successfully overcome this potential barrier within their industry. In other words, they must be prepared and proactive.
The number one way to ensure you are prepared for an FDA audit is to properly train and empower your employees by implementing eLearning and continual employee development procedures. It is however important that medical device manufacturers and others in the life sciences industry ensure that they only validated software systems and platforms to so they are in compliance with Part 11 regulations.
The following are some of the top tips for training your employees to ensure your organization passes an FDA audit:
Thoroughly Train Every Employee
When dealing with an FDA-regulated industry, the most important thing to remember is that every employee needs to be trained and trained well.
For many medical device manufacturers, particularly start-ups or smaller companies, it may be impossible to provide the required level of in-depth, in-person training to each employee. That is why eLearning has become so pivotal to medical device manufacturers—it allows for the rapid dissemination of a lot of information over a broad audience, so you can ensure your entire team is well-trained while saving time and money.
Maintain Detailed Records
Again, this is one of the primary reasons eLearning is vital to training medical device manufacturing team members.
Part of an FDA audit requires you to produce records that demonstrate how your employees have been trained on regulatory standards. With eLearning, you can track the progress of your employees, find where there are problems with training, and keep detailed records of exactly how your employees are being trained. Download our free white paper on how ot prepare for an FDA inspection.
You can utilize eLearning to not only track attendance and progress of certain modules but also as a way to issue certificates. These are, generally, extremely important to a successful FDA audit.
Make Regulatory Training Relevant
One of the biggest roadblocks to effectively training your employees to pass an FDA audit is the fact that it is difficult for employees to see how the information is relevant to their lives. It is important when designing coursework that you lay this out clearly.
This will make them more likely to retain the information, particularly in the face of an FDA audit. Could you make sure your safety training courses are up-to-date?
Make it simple for employees to understand the relevance of their training—it is easier to engage employees when objectives and concepts are clear and concise.
It may be necessary to provide a variety of methods to increase the relevancy of information, including case studies, scenarios, and interactive discussions or questions.
Make It Easy to Revisit and Refresh Information
Regardless of how effective your FDA and regulatory training is, employees may still need to refresh their knowledge.
Make eLearning modules easy to navigate so they can easily access the information they need without having to complete the entire course repeatedly. You can do this through the use of unlocked navigation styles, as well as the addition of components like an index or table of contents.
Similarly, make eLearning coursework accessible on mobile devices so employees can always find what they need.
With eLearning, it is easy to change or update coursework quickly, which is often necessary since FDA regulations change quickly. So, you can make these additions and keep the rest of the coursework the same, saving both time and money for your organization.
An FDA audit does not have to be a heart-stopping prospect if you are a medical device manufacturer. Your team is your best asset in the face of an audit if they are properly trained. eLearning provides tremendous advantages for medical device manufacturers regarding regulatory and compliance training and gives manufacturers ample opportunities to ensure they have a well-trained workforce. When you work with eLeaP, you can be sure you have a team with over 17 years experience working to make sure your organization stays in compliance.