Web-based On-line GMP Training System™
GMP, QSR and FDA
Training Materials for Compliance Looking for Instructor led GMP Training System™?
- Click here
Looking for Interactive Computer-based GMP Training System™?
- Click here
Our Web-based On-line GMP Training System™
is designed for you to use with new employees,
temporary employees, contractors, or even with veteran employees
to freshen their knowledge about GMP regulations. Our
Web-based On-line GMP Training System™
is a comprehensive overview of the cGMP regulation, prepared in twelve
modules.
Each module includes a ten question test and a certificate of completion
Simple and easy to use!
Review and Purchase
English modules - Click here
Review and Purchase Spanish modules
- Click here
Available in both English
and Spanish
Preview
a sample module - Click here
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Customize our Web-based On-line training
for your company. Link to your servers and
your employees have access with a click.
Call us at 714-289-1233 to find out how quick
and easy we can make this happen
Click here
for pricing info |
- Give your employees direct access to GMP Training
on-the-web
- Includes a comprehensive Learning Management System
- Track your employees' progress and test scores
- Generate training reports
- Includes Course Developer software - create your own
courses to add to the menu
- Includes unlimited training and support
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Questions?
Call us at 714-289-1233
These twelve modules comprise a comprehensive
course in the fundamentals of Good Manufacturing Practice, GMP. GMP is a
federal regulation developed and enforced by the United States Food and
Drug Administration (FDA) to ensure that pharmaceutical and medical
device products are safe, pure, and effective. All pharmaceutical and
medical device manufacturers within the United States or who intend to
market their products within the United States are required to comply
with GMPs. All employees of these companies are required by the GMP
regulation to be trained in GMP. This course can help you meet this
requirement.
Each module is designed to take an
individual from 10 to 20 minutes to complete. Once you purchase a
module or the complete system, you will have 90 days to complete it.
Click here or scroll down
for a complete description of each module.
Have several people that need training? Call us for
group discounts 714-289-1233 Pacific time.
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Spanish Edition - Espanol |
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The History and Evolution of Good Manufacturing Practice |
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Descriptions of the Twelve Modules
The History and Evolution of Good Manufacturing Practice
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
The evolution of Food and Drug laws and regulations
·
Key milestones in FDA law
Our Customers are Called Patients and They Trust Us
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Our customers are called patients
·
The notion of trust
·
The role of the FDA
·
Determining the cost of failure
·
The consequences of failure
·
The role of consistency
·
The aim to have happy customers
Writing Good and Effective Procedures
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Written procedures – a fundamental of Good
Manufacturing Practice
·
Identifying a well-written procedure
·
Requirements for writing effective procedures
·
Requirements for controlled documents
Writing It Down! Keeping Good Records Part 1
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Good record keeping – a fundamental of Good
Manufacturing Practice
·
Why so much paperwork is required
·
The importance of keeping accurate records
·
The first four record keeping requirements
Writing It Down! Keeping Good Records Part 2
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Good record keeping – a fundamental of Good
Manufacturing Practice
·
Why so much paperwork is required
·
The importance of keeping accurate records
·
The final six record keeping requirements
Following Our Procedures for Consistency
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Following procedures – a fundamental of Good
Manufacturing Practice
·
The importance of written procedures in producing
consistently high quality products
·
What to do when you can’t follow the written procedure
·
Reasons why written procedures are sometimes not
followed
·
Consequences of not following written procedures
Managing Our Materials to Prevent Contamination, Mix-ups, and Errors
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions. Your
test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Materials management – a fundamental of Good
Manufacturing Practice
·
Definition of materials
·
The importance of a quarantine area for unreleased
materials
·
Sampling, testing, and release of materials for use
·
Raw materials, work-in-process, and finished goods
materials
·
Final product testing and release
·
Accurate record keeping
Being Sure – Checking and Double Checking
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Checking a double checking – a fundamental of Good
Manufacturing Practice
·
Striving for accuracy in approaching work
·
Utilizing a line clearance procedure
Keeping Things Clean – Guarding Against Contamination
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline
·
Keeping things clean – a fundamental of Good
Manufacturing Practice
·
Definition of contamination
·
Sources of contamination
·
Types of contamination
·
Cross-contamination
·
What to do when you see potential contamination
Keeping Our Buildings and Equipment in Good Shape
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Building and equipment maintenance – a fundamental of
Good Manufacturing Practice
·
Why maintenance is so important
·
GMP requirements for building and equipment
maintenance
·
Calibration of equipment requirements
·
What to do when observing any condition which could
lead to contamination, mix-ups, or errors
How Am I Doing? Performing Self Audits
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Audits – a fundamental of Good Manufacturing Practice
·
Why we perform audits
·
Six areas to check when conducting an audit
·
The benefit of conducting audits
People! The Key to GMP Compliance
Description:
This module is designed to take from ten to twenty minutes to
complete. At the conclusion is a test comprised of ten questions.
Your test score will be saved. When you complete a module and test
successfully, you can print a certificate of completion.
Outline:
·
Customer trust – a fundamental of Good Manufacturing
Practice
·
Our competence is our customers’ expectation
·
GMP requirements for training, education, and
experience
·
The consequences of failure
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