FDA-regulated
industries are those that are governed by the rules set out by the FDA. The
primary intention of these regulations is to ensure the quality and processes
of the products that are regulated. This is necessary for a number of reasons.
When people consume products, there are bound to be several risks from these
products, since they affect the consumers in a number of ways directly. A
certain kind of food may carry the risk of causing infection. Another product
such as a medical device may carry the risk of being used improperly and
causing health issues to the user.
It is to contain and mitigate these risks that the FDA regulates
several industries. These regulations are spelt out in the form of best
practices such as Good Laboratory Practice (GLP), Good
Manufacturing Practice (GMP), and Good
Clinical Practice (GCP), 21 CFR Part 11, and so on. These are coded in
Title 21 of the Code of Federal Regulations (CFR) in all its subparts and
sections, a regulation which deals with Quality System Regulations (QSR). Title
21 governs all the provisions of legislations concerning the FDA, the Drug
Enforcement Administration (DEA), and the Office of National Drug Control
Policy (ONDCP).
A
practical solution for avoiding risks associated with noncompliance
Since these codes are of a very complex nature and are difficult
to enforce; it is important for organizations that come under the purview of
these legislations to be trained in the important areas of FDA compliance.
Enforcement of these standards is mandatory, and the FDA doesn’t care about
whether the organization has a proper understanding of these provisions and their
requirements or not. Noncompliance is an action that invites serious punitive
steps from the FDA. It is for this reason that all employees in an organization
that is in any of the regulated industries need to get thoroughly trained on
how to understand, interpret and implement the relevant provisions that apply
to them.
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few training providers do offer courses about all aspects of all FDA Regulated Industry
Training. NetZealous LLC, a Fremont,
CA-based professional trainer with considerable experience and a high
reputation, is one of them. Since 2008, NetZealous LLC has been offering all FDA Regulated Industry
Trainings under its premium brand, GlobalCompliancePanel. GlobalCompliancePanel is a
very renowned provider of FDA-regulated industries.
NetZealous LLC has some of the most reputable experts drawn from
around the globe and across all industries. FDA Regulated Industry
Training is effective and useful only when it is
taught by experts, since it is their knowledge that makes a difference, as it
is they who are more experienced and better placed to understand the finer
details and nuances of the FDA regulations.
Many experts who impart NetZealous LLC’s FDA Regulated Industry
Training are advisors to the FDA, which is perhaps the best guarantee of their
quality of trainings. They understand the real depth of the regulations, making
their trainings highly valuable and easy to implement.
To make learning easier and more effective, NetZealous LLC employs
multiple modes of training. It offers these modes based on the convenience of
the attendees. It imparts FDA Regulated Industry
Training through these modes:
Webinars:
These short duration web seminars are ideal for professionals who need
understanding of a particular point or area of a regulation or a law or a
practice. This is offered at the participant’s convenience, at a location of
her choice and over a short period of time. This makes webinars a popular
mode of NetZealous LLC’s FDA Regulated Industry
Training.
Seminars:
These are usually spread over a couple of days, and are held at venues where
the expert and the participants discuss issues across the board, meaning the
expert is physically present to offer insights and clarifications over the
chosen topic. At these seminars,
the participants also get to interact with their industry peers and colleagues.
In-house
trainings: NetZealous LLC offers FDA Regulated Industry
Training to organizations that want a high number of participants to take part
in these trainings. Usually, onsite trainings are given when the number of
participants is too high for a seminar.
In-house
consulting: A very popular mode of NetZealous LLC’s FDA Regulated Industry
Training; in-house
consulting is offered to organizations that have a particular issue or pain
point to be addressed. In this mode of NetZealous LLC’s FDA Regulated Industry
Training; the expert comes down to the client’s location of convenience and
thoroughly understands its problem. After a complete understanding and analysis
of the issue; the expert offers solutions to the client. NetZealous LLC has
helped many organizations solve many of their burning issues with this mode of FDA Regulated Industry
Training.
NetZealous LLC offers FDA Regulated Industry
Training in all the areas that are important for those in the regulated
industries. These include:
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Surgical Instruments
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Pharmaceuticals
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Biologics
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Software
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Embedded Technologies
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Energy and Utility
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Payment Card Industry (PCI), etc.
