Not a Member?

Gain industry knowledge, learn best practices, network with peers, and advance your career with the largest not-for-profit association in the pharmaceutical industry.

Join now and get Member Pricing on your purchase!

Learn More
* ISPE does not pay customs or duties on international shipping.
Shipping and Return Policy
Publication Order Form

Guidance Document License Agreement

The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser.

Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.

Membership discounts are available only to current members and are intended for individual use of the guides, not for resale.

View the Guidance Document License Agreement   

 

 

 

This highly interactive pre-recorded online course reviews the Production System and its importance within the USFDA Systems Inspection Approach. The course discusses the manufacturing production and process control activities and procedural and documentation requirements, examines validation processes and reviews production personnel work responsibilities, including legal requirements of training for production personnel.

The course includes pre- and post-assessments, a downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all Web links discussed.


This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

Approximate Course Duration: 45 minutes (this is a self-paced course)

*NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

Member Price: $ 250.00
Non Member Price: $ 480.00
Item #: WEBPREPSUS