The 21 cfr part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations.

Objectives

The objective of this free webinar is to share the basic principles of the 21 cfr part 11 Requirements. This session will provide you with information and will allow you to understand the ins and outs of this regulation.

Contents

• The History of 21 CFR Part 11: When and Why was This Regulation Adopted?
• What documents and signatures does Part 11 apply to? And what documents and signatures are outside the scope of the regulations?
• Part 11 Technical, procedural and documentary requirements for electronic records, electronic signatures and open systems
• FDA Guide to Part 11 Compliance
• Step-by-step methodology for executing your Part 11 compliance project
• Actions and Trends in FDA’s Enforcement of 21 CFR Part 11
• Examples of Recent FDA Warning Letters for Electronic Records Violation
• Thoughts on the Future of Part 11

Attendees

Anyone interested in USFDA 21 CFR Part 11

General Information

– Training materials will be distributed
– A Certificate of Attendance will be issued to the participants who have attended the training course.

Speaker

Kossi Molley, LSSBB, Chartered Trainer – Managing Consultant