Facing an FDA audit in the medical device manufacturing industry

If you are a medical device manufacturer, you already understand the huge role regulations and regulatory agencies play in your business. In particular, the FDA.

The FDA audit is one of the most anxiety-producing prospects for medical device manufacturers, and for many manufacturers, is also the most difficult part of their industry.

When you are placed on the FDA’s watch list, it has a huge impact on the way you do business, and the way potential investors and customers see your company.

Rather than trying to deal with the aftermath of a failed audit, medical device Facing an FDA audit in the medical device manufacturing industrymanufacturers should put in place certain measures that will ensure they are able to 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.

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 not just trained, but trained well.

For many medical device manufacturers, and in particular start-ups or smaller companies, it may be completely 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 so 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 are able to 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.

You can utilize eLearning to not only track attendance and progress of certain modules, but also as a way to issue certificates. All of 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. 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 laid out clearly and concisely.

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, it may still be necessary for employees to refresh their knowledge.

Make eLearning modules easy to navigate so they can easily access information they need, without having to complete the entire course all over again. 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 course work accessible on mobile devices so employees can always find what they need.

With eLearning it is also easy to change or update coursework quickly. Which is often necessary since FDA regulations change quickly. So, you can simply 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 in terms of regulatory and compliance training, and gives manufacturers ample opportunities to ensure they  have a well-trained workforce.

 

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