PTI - international

Documentation is a fundamental requirement of the GMP, GLP and GCP regulations – collectively known as "GxP." In the FDA's view, "If you didn't document it, you didn't do it." When inspectors show up at your facility, expect a close examination of your documentation and subsequent regulatory action if your documentation is missing or incomplete. This highly informative, interactive course provides the skills and knowledge necessary to meet the FDA's expectations for GxP documentation and avoid such action. Participants learn how to write essential documents, maintain documentation, audit documentation, ensure change control, implement proper review and approval processes, and much, much more. Numerous case studies and interactive exercises are incorporated to guarantee a practical and useful learning experience.