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.