IT company InfoStrength and Greenwood CVR, a regulatory consulting firm in RTP, will be hosting a training series to assist life science professionals understand and cope with the new FDA Part 11 guidance.

The InfoStrength/Greenwood CVR training series will be held in multiple locations throughout North Carolina, including RTP on Nov. 4, Winston-Salem on Nov. 18 and Wilson on Nov. 20.

The seminar will specifically clarify the scope, application, and impact of the FDA’s new Part 11 guidance. The training will cover in detail what the new regulatory focus on risk assessment means for operations and how to proactively mitigate risk to the organization.

“There is a lot of confusion about what has changed and what has remained the same with the latest risk-based guidance for 21 CFR Part 11 from the FDA,” said Rita Geiger, CEO and president of InfoStrength. “Our one day training session will clarify for life science professionals the scope and impact of current FDA thinking.”


Greenwood CVR: