This presentation will enable attendees to understand the background and basics of regulatory compliance auditing. They will learn proper audit conduct as well as how to prepare and plan for regulatory compliance audits. Audit observation classification will be covered as well as proper audit report writing.

The presentation will also discuss different global agencies’ expectations of analytical equipment qualification in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Understanding what documents are required for equipment qualification and how to manage those documents, as well as data collection, testing, and proper analytical equipment performance qualification, will also be covered.