Course Overview:

This comprehensive course will go into the fundamentals of validation for regenerative medicine technologies, a key step in the product development life cycle. Participants will learn the best practices in approaching validation in the changing regulatory environment and in managing risks.

Key topics include:

• Validation vs. verification
• The FDA’s involvement in inspections and enforcement
• How to adhere to cGMPs
• Pitfalls of validation documentation
• Equipment and systems qualification

The course, offered by the Regenerative Medicine Engine, will be taught by Rosa Fernandez. A former instructor at Wake Tech Community College, Fernandez also brings nearly two decades of experience as a regulatory affairs specialist and quality assurance manager in the biopharmaceutical industry.
Whether you’re ready to begin validating your product or just want more insight into the validation process, this course provides the essential knowledge and actionable strategies to help you bring a technology to market.