NetZealous LLC at your facility

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NetZealous LLC at your facility
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• To start with, let us put you at ease with the
  topic of this discussion NetZealous LLC at your
  facility is not the same as FDA at your
  facility! In fact, if anything, it is only to
  help originations tide over the tensions
  associated with a visit from the FDA that
  NetZealous LLC comes to your facility.
• Having someone from the FDA come over to ones
  facility is one of the most dreaded of activities
  for any organization in any of the FDA-regulated
  industries.

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An unwelcome guest

• This is a scenario no organization likes to be
  in, because an FDA citation, a 483 or a penalty
  will overturn years of effort. It can ruin your
  resources in a big way. It can wreck your name
  and what not. This is not to suggest that the FDA
  is dictatorial arbitrary. Not really it is just
  a stickler to rules and requirements.

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• It gets down to the minutest of these rules and
  regulations to such a hairsplitting extent that
  the FDA inspector is bound to be source of
  jitter, even if the organization has done what it
  could to the best of its ability, and the FDA
  inspector is merely carrying out his duty. These
  rules and requirements are so painstaking that
  even the best qualified person in any
  organization is hard pressed to come up with a
  compliance program that completely meets the
  FDAs innumerable requirements.

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• This is just why an organization in a regulated
  industry needs some external assistance for
  clearing the matter. This is where the services
  of an organization like NetZealous LLC can be of
  immeasurable value.
• Having NetZealous LLC at your facility puts
  organizations means you are put at total ease
  with relation to their specific needs and
  requirements. This is because having NetZealous
  LLC at your facility is the surest means to
  understanding your compliance problems and pain
  areas. This is the reason for the visit from
  NetZealous LLC.

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Who visits you from NetZealous LLC, and why?

• This is the all-important question. Having
  NetZealous LLC at your facility means insulating
  your organization from the dread that accompanies
  a visit from the FDA. We will get an Expert to
  come down to your facility to address the
  specific and particular issues you could be
  facing with FDA compliance. When an Expert from
  NetZealous LLC visits your facility, you can rest
  assured that your organization will have no fear
  as far as meeting the FDAs regulatory
  requirements is concerned.

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• NetZealous LLC at your facility is a means for
  staying compliant with regulatory requirements
  set out by the FDA. We make sure that your
  expert, who arrives at your facility, will
  thoroughly equip you with the knowledge needed
  for staying compliant with the FDAs regulatory
  requirements.
• The first step after having NetZealous LLC at
  your facility is a complete understanding of your
  pain areas and problems. The expert from
  NetZealous LLC discusses the problem you are
  facing with compliance in its entirety. She will
  then help you understand the problems being faced
  by you, and will help you sort them out.

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More than just FDA compliance

• Ensuring that your organization meets regulatory
  compliance is just one of the areas on which
  NetZealous LLC offers you guidelines and
  suggestions. For more than eight years,
  NetZealous LLC has been a provider of
  professional trainings for the regulated
  industries, human resources, healthcare and IT.
• In all the areas concerning these industries,
  NetZealous LLC offers professional trainings.
  When NetZealous LLC comes over to your facility,
  it will offer you all the specialized and unique
  training that you need for staying compliant with
  regulatory requirements, as well as for getting
  your problem areas sorted out.

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• NetZealous LLC at your facility will also ensure
  that you have complete knowledge of and stay
  updated with the latest industry best practices.
  NetZealous LLC at your facility will also ensure
  that you undertake in-house trainings for a
  number of areas on which you may have issues.
  These in-house trainings ensure that you both
  stay compliant with regulatory requirements and
  understand the nitty-gritty of the latest updates
  or legislations concerning your industry.

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In-house trainings

• Having NetZealous LLC at your facility and
  offering in-house trainings for your organization
  is a great means to ensure that professional
  trainings that are relevant and important are
  also inexpensive, accessible, consistent and of
  high quality.
• These in-house trainings are designed to help
  organizations get the most out of the expert
  training offered by NetZealous LLCs experts.
  These experts are chosen for the good name they
  have earned over the years while working for the
  industry. They are also completely knowledgeable
  about the core areas of regulatory compliance.

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• Having NetZealous LLC at your facility ensures
  that you do not miss out on their experience and
  learning and that you make the best out of them.

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Problem areas you will address by having
NetZealous LLC at your facility

• By having an industry-best expert come over from
  NetZealous to your facility you address all the
  issues and pain areas relating to all the topics
  of importance and relevance from the regulatory
  compliance.

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These are the areas that you can address by
having NetZealous LLC at your facility

• 21 CFR Part 11
• Analytical Development and Formulation, Drug
  Process Development
• Audit Preparation
• Bi-analytical method development
• Bioresearch
• Clinical Research / Drug-Device Development
• Clinical trial
• Contract Manufacturing Compliance

• FDA Audit Inspection
• FDA quality system
• Food Safety
• GCP compliance
• Global Regulatory Submission
• Immunogenicity and Bioassay Method Development
• IND, IDE, CAPA, GMP/cGMP Compliance PMA's
• ISO 13485/EN46000 and ISO 9000
• Laboratory Testing
• Lean Manufacturing
• Manufacturing, Packaging and Labeling

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