Professional trainings from NetZealous LLC on how to prepare for an FDA inspection

Fremont, CA: July 18, 2016
NetZealous LLC, a professional trainings provider in the areas of regulatory compliance, human resources, healthcare and IT, offers trainings for professionals in the field of FDA-regulated industries on how they need to prepare themselves for an FDA inspection. This learning is of crucial importance to such professionals, as the FDA is considered one of the world?s most stringent regulatory bodies. It expects the facilities it inspects to go by certain rules. NetZealous LLC?s trainings also familiarize participants with the do?s and don?ts of an FDA inspection.
An FDA inspection is one of most anxious moments for a facility in a business that is FDA-regulated. Although there are strict rules concerning an inspection; most businesses that are subject to an FDA inspection are jittery nevertheless, because of the stringency of possible actions that could follow from a visit if the facility doesn?t live up to expectations.
Having to prove the suitability and efficiency of their process
It is true that the FDA cannot take arbitrary actions and that it is quite amiable and conciliatory to the needs of the manufacturer whose facility it is inspecting, but manufacturers are in a tight spot when it comes to having to prove to the FDA inspector that the method they have chosen for a certain action is suitable for its business and that it takes the business to the desired result while being compliant with the regulatory expectations and guidelines. This is a major area that these manufacturers have to satisfy, because many of the FDA?s guidelines are nonbinding, but are open-ended and subjective, leaving them open to interpretation.
If this is one of the main areas of concern and difficulty for manufacturers that are subject to an FDA inspection; they have to also be within the confines of unwritten codes of behavior, another area of subjectivity. All these cause nervousness to manufacturers when it comes to an FDA inspection. If the inspector feels that the facility is not up to the mark in some respects; she can also initiate penal actions against the facility.
Think like the FDA to get it right
?It is to acquaint professionals in the FDA-regulated industries that our trainings are designed. The reason for which they need to be trained is simple: They can go by the book, but could still leave a small loophole open, which could afford a good reason for the FDA to take action. Our trainings are from experts who have been with the FDA for many years. This gives them complete knowledge of the way the FDA thinks. The aim of our trainings is to give participants an understanding of the FDA?s line of thinking. This is the best way to equip them with ways of handling inspections. This is a very solid line of defense against an FDA inspection?, said Satisha Naraharimurthy, Founder and CEO of NetZealous LLC, a Fremont, CA-based professional trainings provider in the areas of regulatory compliance, human resources, healthcare and IT.
Making it happen without hassles
Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous LLC says that the primary aim of NetZealous LLC?s trainings is to ensure that the professionals in charge of facilities or activities that are subject to an FDA inspection should not be caught unawares when it comes to important procedures and ways of conducting themselves. ?We want to ensure that the FDA inspection proceeds smoothly and according to plan, which is how it should ideally be. In fostering this, we believe we contribute our mite in the overall processes involved in the manufacture of regulated products?, he said.
This is a view shared by Liju Mathew, Co-Founder and Chief Business Development Officer at NetZealous LLC. He likes to think that with its professional trainings, NetZealous LLC ?would like to be a cog in the wheel by conditioning professionals in the regulatory industries on the lines of the FDA?s thinking. Our trainings also throw light on the vital aspects of an FDA inspection, such as the documents to have in place and the ways of maintaining them, what to say and what not to, what to do post-inspection, ways of dealing with penal actions, and a whole bunch of important related areas. The eventual aim is to contribute to the overall regulatory process?.
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