This webinar will discuss the fundamentals requirements for system which gets audited during FDA inspection and how to conduct internal audit, report writing and audit follow ups.
Why Should You Attend:
FDA inspection / audits are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, food and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals.
This course will examine the fundamental requirements for all systems subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions. This webinar will discuss details of Auditing of Systems : Quality, Facilities and Equipment, Materials, Production, Packaging/Labeling, Laboratory Controls.
In addition, this course will include a list of relevant regulations and guidelines and demonstrate how to monitor industry practices to stay “current” with FDA requirements (cGMPs and GLPs).