Basic Principles of Computerized Systems Compliance Using GAMP® 5, Including Revised Annex 11 and Part 11 Update (T45) - Updated!
This Classroom training course has been updated to include the new revised EU GMP Annex 11, and an update on 21 CFR Part 11.
This two or three-day fundamental course* introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements.
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scalable and efficient system lifecycle, Quality Risk Management, GAMP® categories, the role of the supplier, and the selection of appropriate specification and verification activities.
Course Topics Include:
Take Back to Your Job
Attendance Suggested for:
Community of Practice (COP)
This training course is of particular interest to existing and future members of the GAMP® Community of Practice (COP).
*Please click the "Locations and Registrations" table to select the two or three-day sessions.
Daily Schedule and Pricing
Virtual, United States15 - 16 Sep 2020
Mail or Fax Registration
Not paying by credit card? Use the registration form to pay by mail or by fax.
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Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, email@example.com.