PTI - international

FDA regulations require "written procedures" for all systems which impact product quality and safety, and the agency's field investigators regularly cite drug manufacturers for noncompliance with these requirements. Yet FDA has neither defined what a Standard Operating Procedure (SOP) is nor issued formal guidance regarding how to organize, write and manage SOPs! So how are you supposed to know what to do? This highly informative, interactive training course provides clear, expert instruction on all aspects of SOP development and maintenance for your GxP needs. On Day One, the course focuses on identifying where SOPs are required in the GxPs; the role of SOPs; best practices for formatting SOPs; and writing techniques. On Day Two, topics include documentation controls; how to manage SOPs; 21 CFR Part 11; and FDA inspection issues. The course includes many opportunities for group discussions and exercises. It enables you to gain the skills and knowledge necessary to meet the FDA's expectations for your SOPs and avoid regulatory enforcement actions.