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The 21 CFR Part 11 regulation handbook is used in association with ISPE training courses. Attendees of the training course receive a complimentary copy of this publication.
GAMP® Basic Principles Training Course (T07)
GAMP® Part 11 Training Course (T08)
GAMP 5®, Annex 11/Part 11 Basic Principles Training Course (T45)
ISPE members located in nations with emerging economies* are eligible for a 50% discount on publications from the regular member price. To receive the discount, members must be logged in with their ISPE member account. Contact Member Services at ask@ispe.org for more information or if you have questions about your membership status or this discount program. Discounts do not apply to Techstreet document downloads.
*Based on the World Bank's system for classifying national economies by GNI per capita. Includes low-income, lower middle-income, and upper middle-income economies. To learn more about the World Bank classification system, please click here. Currently includes the following nations, except where international sanctions apply: