Now Available

This course is intended to provide the customer with an understanding of Parts 50, (Protection of Human Subjects), 54, (Financial Disclosure by Clinical Investigators) and 56 (Institutional review boards).

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8? Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit) View Instructions

Course Description:

Training Modules: 8
Total Training Time: 6 Hours
Total Frames: 245
Total Checks-On-Learning: 32

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 50 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID IF the examination is passed.

Available
This course is intended to provide the customer with an understanding of Parts 210 and 211 for the manufacturing of pharmaceuticals to be sent into commercial distribution.

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8?   Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit)   View Instructions

Course Description:

Training Modules: 8
Total Training Time: 3-4 Hours
Total Frames: 245
Total Checks-On-Learning: 32

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 50 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID IF the examination is passed.

Training Module One - Admin and Introduction Module
9 Frames 
10 minutes

Training Module Two - 210 Definitions / 211 A-C Module
Contains the definitions from Part 210 and 211 Subparts A-C including; General Provisions, Organization and Personnel, and Buildings and facilities.
53 frames 
60 minutes
7 Checks on Learning

Training Module Three - 211 D-F Module
Contains 211 Subparts D-F including; Equipment, Control of Components and Drug Product Containers and Closures, and the Production and Process Controls.
49 frames
50minutes
7 Checks on Learning

Training Module Four - 211 G-I Module
Contains Subparts D-F including; Packing and Labeling Control, Holding and Distribution, and Laboratory Controls.
81 frames
70 minutes
11 Checks on Learning

Training Module Five - 211 J and K Module Contains Subparts J and K including; Records and Reports, and Returned and Salvaged Drug Products.
52 frames 
50 minutes
7 Checks on Learning

Training Module Six - Course Summary
Contains a summary of the training received during the course.

Training Module Seven - Testing Module
Contains the test module.

Training Module Eight - Certificate Module
Contains the instructions for and a method to print your Certificate of Completion.

Available
This course is intended to provide an understanding of Part 58, Good Laboratory Practices for Nonclinical Laboratory Studies regulated by the Food and Drug Administration.

This course will provide a comprehensive look at good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products.

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8? Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit) View Instructions

Course Description:

Training Modules: 8
Total Training Time: 3 Hours
Total Frames: 156
Total Checks-On-Learning: 17

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 50 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID IF the examination is passed.

Training Module One - Admin and Introduction Module

8 Frames
5 minutes

Training Module Two - Subpart A

34 frames
40 minutes
2 Checks on Learning

Training Module Three - Subparts B, C, and D

33 frames
40 minutes
4 Checks on Learning

Training Module Four - Subparts E, F, and G

38 frames
40minutes
5 Checks on Learning

Training Module Five - Subparts J, and K

42 frames
50 minutes
6 Checks on Learning Training Module Five - Course Summary

Contains a summary of the training received during the course.
1 frame
5 minutes
No Checks on Learning

Training Module Six - Testing Module

Contains the examination module for the course.

Training Module Seven - Certificate Module

Contains the instructions and the method to print your Certificate of Completion.

Now Available

This course is intended to teach manufacturers implementing modern quality systems and risk management approaches to meet the requirements of FDA’s GMP regulations.

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8? Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit) View Instructions

Course Description:

Training Modules: 8
Total Training Time: 6 Hours
Total Frames: 245
Total Checks-On-Learning: 32

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 50 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID IF the examination is passed.

This course is not yet available

This course is intended to provide the customer with an understanding of the Good Manufacturing Practice (GMP) for the manufacturing of active pharmaceutical ingredients.

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8? Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit) View Instructions

Course Description:

Training Modules: 8
Total Training Time: 6 Hours
Total Frames: 245
Total Checks-On-Learning: 32

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 50 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID IF the examination is passed.

Available
This executive course will provide 1 to 1.5 hours of condensed refresher training on the GMPs for finished pharmaceuticals. This course is recommended for industry professionals only.

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8? Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit) View Instructions

Course Description:

Training Modules: 4
Total Training Time: 1 to 1.5 Hours
Total Frames: ~200

Total Checks-On-Learning: None

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 25 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID if the examination is passed.

Training Module One - 211 Sub Parts A thru C 
41 Frames 
15 minutes

Training Module Two - 211 Sub Parts D thru F 
42 frames 
15 minutes

Training Module Three - 211 Sub Parts G thru I
72 frames 
25 minutes

Training Module Four - 211 Sub Parts J thru K 
45 frames
20 minutes

Available
This course is intended to provide the customer with an understanding of Part 225 for the manufacturing and distribution of medicated feeds.

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8? Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit) View Instructions

Course Description:

Training Modules: 7
Total Training Time: 2-3 Hours
Total Frames: 79
Total Checks-On-Learning: 10

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 50 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID IF the examination is passed.

Training Module One - Admin and Introduction Module
9 Frames
10 minutes

Training Module Two - Part 225, Modules A and B
Contains Subparts A and B including; General Provisions and Construction and Maintenance of Facilities and Equipment.
23 frames
50 minutes
2 Checks on Learning

Training Module Three - Part 225, Modules C and D
Contains Subparts C and D including; Product Quality Control, and Packaging and Labeling.
31 frames
60 minutes
4 Checks on Learning

Training Module Four - Part 225, Modules E thru I
Contains Subparts E thru I including; Records and Reports, Facilities and Equipment, Product Quality Assurance, Labeling, and Records.
26 frames
50 minutes
4 Checks on Learning

Training Module Five - Course Summary
Contains a summary of the training received during the course.

Training Module Six - Testing Module
Contains the test module.

Training Module Seven - Certificate Module
Contains the instructions for and a method to print your Certificate of Completion.

Available
This executive course will provide condensed refresher training on Part 225 for the manufacturing and distribution of medicated feeds.

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8? Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit) View Instructions

Course Description:

Training Modules: 7
Total Training Time: 1 -2 Hours
Total Frames: 79
Total Checks-On-Learning: 0

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 25 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID IF the examination is passed.

Training Module One - Admin and Introduction Module
8 Frames
10 minutes

Training Module Two - Part 225, Modules A and B
Contains Subparts A and B including; General Provisions and Construction and Maintenance of Facilities and Equipment.
21 frames
25 minutes
0 Checks on Learning

Training Module Three - Part 225, Modules C and D
Contains Subparts C and D including; Product Quality Control, and Packaging and Labeling.
27 frames
35 minutes
0 Checks on Learning

Training Module Four - Part 225, Modules E thru I
Contains Subparts E thru I including; Records and Reports, Facilities and Equipment, Product Quality Assurance, Labeling, and Records.
27 frames
35 minutes
0 Checks on Learning

Training Module Five - Course Summary
Contains a summary of the training received during the course.

Training Module Six - Testing Module
Contains the test module.

Training Module Seven - Certificate Module
Contains the instructions for and a method to print your Certificate of Completion.

Available
This course is intended to provide a comprehensive look at the History of Good Manufacturing Practice in the United States in three separate time periods: 1902–1938, 1938–1969, and 1969 to today.

This course will provide a comprehensive look at the History of GMP from 1902 to today. The course answers questions like who are Harvey Wiley and Estes Kefauver and what role they played in the History of GMP and what the FD&C Act of 1938 is. The course traces the regulation of Good Manufacturing Practices for the products we use everyday like; finished pharmaceuticals, medical devices, and the food we eat. If none of this rings a bell, you should definitely take this course.

System Requirements:

To best view the training within our site, it is recommended you have the following System Requirements:

Windows 2000,XP Pro,XP Home (Not Tested on Vista Systems)
300 MHz processor
256 MB RAM
Internet Explorer 6 or later
Macromedia Flash Player 8 (Recommended)
Need Flash Player 8? Click Here
Screen Resolution of 1024x768
Color Quality Highest (32 bit) View Instructions

Course Description:

Training Modules: 7
Total Training Time: 1 Hour
Total Frames: 74
Total Checks-On-Learning: 0

Testing: Two Attempts. (If the exam is failed, the learner will return to the lesson for an Independent Review. After a failure on the second attempt, there will be no further examination. The certificate of completion will not be issued.)
Duration: No Time Limit
Number Examination Questions: 20 (Each Question Randomly Selected)
Type: Multiple Choice (Answers Are Randomly Arranged)

Certificate of Completion: One Certificate will be issued for each login ID, IF the examination is passed.

Training Module One - Admin and Introduction Module

8 Frames
5 minutes

Training Module Two - Early History 1902-1938

27 frames
20 minutes
No Checks on Learning

Training Module Three - Middle History 1938-1969

16 frames
15 minutes
No Checks on Learning

Training Module Four - Late History 1969-Present 

22 frames
20 minutes
No Checks on Learning

Training Module Five - Course Summary

Contains a summary of the training received during the course.
1 frame
5 minutes
No Checks on Learning

Training Module Six - Testing Module

Contains the examination module for the course.

Training Module Seven - Certificate Module

Contains the instructions and the method to print your Certificate of Completion.