FDASmart Inc., FDA Inspection Training Courses, FDA Consultant, FDA Compliance, FDA Audit, FDA Consulting

Overview

	21 CFR Part 11 Compliance (electronic records & electronic signatures)
	Three of FDASmart ’s Training Classes
	Class Title	Description
1	Auditing Information Systems: Are You and Your Vendors Meeting FDA Expectations?	A discussion about conducting an audit or preparing to be audited for compliance with 21 CFR Part 11 regulations (electronic records and electronic signatures.)
2	Computerized Systems Used in Clinical Investigations: FDA Guidance on Part 11 Regulations	A summary of new information in the final (May 2007) version of the guidance, “Computerized Systems Used in Clinical Trials” and how to improve compliance based on this new information.
3	SOPs for Implementing a Risk-Based Approach to FDA Part 11 Compliance	A review and discussion of FDA's risk assessment requirement for evaluating systems that support product quality, safety and record integrity.

21 CFR Part 11 Compliance