Copyright (C) All rights reserved. FoodHACCP.com. For more information send email to
info@foodhaccp.com   TEL) 1-866-494-1208 FAX) 1-253-486-1936
1
Registration
FDA's/OECD cGLP for Nonclinical
Laboratory Studies
Certificate requirements
The course uses a continuous evaluation method
with on-going quizzes to facilitate the information
retention. If your final average is equal or greater
to 70% you will be issued a training certificate. If
your final average evaluation is less than 70%,
you will have to take a final exam and score above
70% to be issued the training certificate.
You want to quickly and efficiently obtain training
on the FDA's Good Laboratory practice (GLP) for
Nonclinical Laboratory Studies


You do NOT have time to allocate a full day to
take a LIVE GLP Training class on the GLP
requirements and 21CFR58,

You want to train more of your staff on the GLP
economically and without having to immobilize
them in a class for a full day,

You want improve your CV and career
opportunities in the Biotechnology and
pharmaceuticals industries with qualifications in
the GLP, by adding this widely industry recognized
course to the education or training section of your
CV,

You want to implement the Good Laboratory
practice for Pharmaceuticals, Medical Device,
Human Food, Neutraceuticals, OR a
non-regulated industry test or research laboratory,

the FDA's online GLP course for Nonclinical
Laboratory Studies is the solution:

It can be taken from anyone's workplace or from
home through the Internet without any time limit to
complete the course. It has "save and exit"
features so that you can do it at your own pace (a
couple of sections per day...).
After registration, there is no time limit on when
you can start or complete the course. You have
complete flexibility in taking the course around
your schedule.
The cost ranges from $158.06 for group training to
$185.95 for individual training. This is an average
60% cost savings on comparable class courses.
The training uses examples and quizzes that give
very good exposures on industry related
implementation issues.
It provides the text of GLP for Nonclinical
Laboratory Studies, FDA Regulatory Office
guidelines on the different requirements, and uses
quizzes to give guidance in implementation of the
requirements. The Code of Federal Regulations
Title 21, Revised as of April 1, 2014, can be
obtained from the U.S. Government Printing Office
via GPO Access
It uses a continuous evaluation method with
on-going quizzes to facilitate the information
retention.
If your final average in the ongoing evaluation is
equal or greater to 70% you will be issued a
training certificate that you can print for 12 hours
(1.2 CEUs) of training on the cGLP for Nonclinical
Laboratory Studies.
If your final average in the ongoing evaluation is
less than 70%, you will have to take a final exam
and score above 70% to be issued the training
certificate.

Satisfaction Guaranteed

Your satisfaction is guaranteed. If you register to any of our
online courses and are not satisfied with the content, let us
know, and BEFORE you complete the course or are issued the
online certificate: we will refund 100% of the registration fee. We
are confident, that like our many other trainees, you will like any
course we offer, take some of our other courses, and also
recommend them to others. We are proud of our achievement,
and want to show it through the explicit satisfaction guarantee
that other trainers cannot offer.
Online Training with a certificate
FDA's cGLP for Nonclinical Laboratory Studies (21CFR58)
Cooperated with Caliso Co.
GLP requirements and 21CFR58
Course objective
This training course has been designed for
individuals involved in manufacturing of Finished
Pharmaceuticals products. It offers in-depth
training on the FDA's GLP requirements of
This course is also useful if you want to
implement the Good Laboratory Practices for a
Pharmaceuticals, Medical Devices, Human Food,
Neutraceuticals, OR a non-regulated industry test
or research laboratory,

Course length
2-3 days (a few hours everyday) are required to
complete the FDA-cGLP for Finished
Pharmaceuticals Training.

Who should attend
Anyone who do not have time to allocate a full
day to take a LIVE class on FDA's GLP for
finished pharmaceuticals, wants to quickly and
efficiently understand what the pharmaceutical
FDA's GLP requirements are, and
implement the GLP without using a consulting firm

Title 21--Food and Drugs
CHAPTER I--FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF
HEALTH AND HUMAN SERVICES
GOOD LABORATORY PRACTICE FOR
NONCLINICAL LABORATORY
STUDIES

58.1 Scope.
58.3 Definitions.
58.10 Applicability to studies performed under
grants and contracts.
58.15 Inspection of a testing facility.
58.29 Personnel.
58.31 Testing facility management.
58.33 Study director.
58.35 Quality assurance unit.
58.41 General.
58.43 Animal care facilities.
58.45 Animal supply facilities.
58.47 Facilities for handling test and control
articles.
58.49 Laboratory operation areas.
58.51 Specimen and data storage facilities.
58.61 Equipment design.
58.63 Maintenance and calibration of equipment.
58.81 Standard operating procedures.
58.83 Reagents and solutions.
58.90 Animal care.
58.105 Test and control article characterization.
58.107 Test and control article handling.
58.113 Mixtures of articles with carriers.
58.120 Protocol.
58.130 Conduct of a nonclinical laboratory study.
58.185 Reporting of nonclinical laboratory study
results.
58.190 Storage and retrieval of records and data.
58.195 Retention of records.
58.200 Purpose.
58.202 Grounds for disqualification.
58.204 Notice of and opportunity for hearing on
proposed
disqualification.
58.206 Final order on disqualification.
58.210 Actions upon disqualification.
58.213 Public disclosure of information regarding
disqualification.
58.215 Alternative or additional actions to
disqualification.
58.217 Suspension or termination of a testing
facility by a sponsor.
58.219 Reinstatement of a disqualified testing
facility

Worldwide Course Recognition:
This online training courses are recognized by all
registrars and hiring companies as objective
evidence of effective training on the particular
standard and regulation. Since 1999, they have
been the most popular and most widely used
training courses in English, with over 15,000
trainees in the US and worldwide. The standards
and regulations are provided online
under licensing of the American National
Standard Institute (ANSI), SAE International, or
courtesy of the Federal Drug Administration (FDA).
Directly Connect to Caliso Registration page
Food Safety Education
Since 1999