This seminar will include overviews of the various regulations that affect laboratories and understand how they drive the audit, including 21CFR Part 11 as so many modern laboratories rely on computer-based data acquisition and reporting. We will provide forms and templates used in conducting audits, and train on when and how to utilize these tools. Each participant will write an audit observation as an auditor, and separately respond as an auditee to an observation and design a corrective action plan. We will explore all the aspects of laboratory operations including test methods validation, notebooks, instrument and equipment qualification, training records and data systems that are subject to audit.
Added by complianceonlinecom on July 24, 2012