System Validation, GAMP Harmonization and P.A.T
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Who Should Attend
This three-day, practical course will be of interest to
professionals in the Pharmaceutical, Biopharmaceutical
and other FDA regulated industries. This includes, but
isn’t limited to-
Automation Managers/Directors
- Technical Support Personnel
- Validation Engineers
- Systems Administrators
- QA/QC Personnel
- User Support Staff
Description
This course is intended to be an overview of the latest
emergent issues of FDA compliance, including: Process
Analytical Technology (PAT); computer system validation;
risk assessment; 21 CFR Part 11; and harmonization with
GAMP4. Now that computers have replaced many of the
manual operations associated with the acquisition and
management of information, it is important to ensure that
appropriate testing and control procedures are applied to
the new systems. This course will cover the available
techniques for verifying that computer systems function as
they are intended to. In addition, the role of procedures
and documentation will be presented.
The computer industry has, for some time, been
developing validation procedures for systems; however,
many of these techniques have not been presented in the
context of international regulations. This course will
address the emerging trends based on industry
experience, including results from recent findings in FDA
computer system audits. There are specific times set
aside to discuss establishing such a validation program in
participants’ respective organizations.