The Center for Professional Advancement, Amsterdam
22-24 October 2007
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 toAutomation Managers/Directors
Systems Administrators
Technical Support Personnel
QA/QC Personnel
Validation Engineers
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.
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