Learn about investigators’ obligations as described by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
US FDA inspectors and corporate auditors must be able to recognize the critical aspects of computerized systems and the documentation needed to demonstrate that they are validated, thus meeting data integrity requirements. This course provides an approach to inspecting/auditing these systems and covers the detailed review of systems that automate part of the production process or part of a quality system.
Learn to meet the FDA’s computerized systems compliance regulations while managing validation activities and reducing validation requirements.
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They are watching.
Computerized systems require an audit trail capability, meaning there is no place to hide when it comes to your data integrity requirements and validation protocol.
Sanctions are severe.
Data integrity issues incur CGMP violations, FDA warning letters and legal actions that lead to FDA 483s and perhaps even warning letters.
Education not inspections.
Federal mandates such as 21 CFR Part 11 regulatory compliance and CGMP guidelines require that you learn current policies for documenting, validating and archiving CGMP data.