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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, online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. Quality system elements reviewed include: annual product reviews, complaint files, discrepancies and failure investigations, change control, reprocessing, returns/salvages, stability testing, quarantine systems, and validation/verification. Additional topics covered include how the International Conference on Harmonization (ICH) documents Q8, Q9 and Q10 relate to and support the quality system. This course is designed to provide broad, fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge.

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 when 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 #: WEBPREQSUS