When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of ensuring safety and reliability of the products.
This makes FDA trainings an absolute imperative for organizations that are regulated by the FDA. They are so important in meeting FDA regulatory requirements that FDA trainings are not just desirable, but indispensable in helping organizations do this. the question is, can’t organizations implement FDA guidelines on their own without the help of trainings?
Well, fact is, they can, but what makes FDA trainings a must is that their implementation in all the fullest details and in the exact prescribed manner is the surest means to avoid confusion or misconceptions or misgivings about implementation of the prescribed FDA guidelines. FDA implementation is not something that an organization can take chances with. Why? The consequences of non-implementation are too grave to do this. Organizations can face the backlash from the general public if their product harms its consumer. Additionally, they can face terrible consequences of a very strong nature from the FDA.
So, now that the need for FDA trainings is beyond doubt, what are the factors that FDA-regulated companies need to keep in mind when undergoing FDA trainings? Let us look at some of the simple but important things to remember about FDA trainings:
First and foremost, the FDA itself prescribes training for the relevant staff in their area of work. Like the ISO, the FDA also makes training for personnel necessary for those in manufacturing necessary to attain proficiency in their work and meet regulatory guidelines.
However, the FDA does not get down to the specifics of the training, i.e., what trainings are to be undertaken by which kind of staff and who should impart this training and how to do it. It leaves this to the discretion of the companies. This being the case, it is necessary for these regulated companies to know simple but important things to remember about FDA trainings.