MAY 30–INDIANAPOLIS, Ind.–Life Science consultants Learning 11 LLC and Theoris, Inc. are hosting a one-hour online seminar entitled “A Practical Approach to Part 11 Compliance: The FDA’s New Part 11 Draft Guidance.”
This online seminar will focus on practical approaches to compliance in response to the significant changes brought about in the new FDA Draft Guidance document.
“Pharmaceutical, medical device and bio-technology companies are impacted by the FDA’s new guidance on 21 CFR Part 11,” said Terry Spartz, vice president of Theoris. “This seminar will help companies understand the impact of the new changes and will outline the components for a risk-based approach to implementing a Part 11 program.”
A practical approach to Part 11 Compliance is the first in a series of “webinars” focusing on the life sciences industry. The Webinar series is the next generation of information delivery where individuals from around the world can participate in a live interactive online seminar using their computer, telephone and internet connection.
Participants can attend the Part 11 online seminar on Thursday, June 12 or Tuesday, June 17 and receive continuing education units (CEUs) upon completion. Cost for the event is $99.00. Registration is available online at www.learning11.com/webinars.html or by calling 317-769-6531.