A general overview of the Quality System will be addressed; therefore, it also provides a basic knowledge of the DAMAS specifications and the FDA’s Quality System/Good Manufacturing Practices. This information applies to auditing any type of quality system. The course covers purpose and scope of an audit; formation of the audit team; types of audits; requirements under DAMAS, ISO, and FDA audits; and components of the audit. Who will benefit the most: Quality/management Representatives, individuals in the lab designated to perform audits, lab owners, lab managers/supervisors, CDT’s, anyone needing Regulatory Standards CE credit. Please disregard the reference made to handouts and the NBC Course code in the presentation. There are no handouts provided for this online course.