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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   

 

 

Selected currency: US Dollars.
 

This highly-interactive, pre-recorded online course reviews the laboratory control system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. This online course introduces laboratory controls, breaks down GMP Part 211, reviews method validation and out of specification results, and provides tips for laboratory notebooks. It also reviews requirements of laboratory equipment, gives insight on laboratory-focused, FDA systems-based inspections, and the common finding of non-compliance.

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: 60 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 #: WEBPRELCSUS