Preparing Research Organizations for Digital Tools and Part 11 Compliance
A complimentary live webinar to help your organization
Is your research organization prepared to take advantage of innovative tools and technologies that are available for clinical research today?
- eReg Binders
- and more
These digital “eTools” can help you improve research efficiency and quality. But they also require additional regulatory compliance activities at the research site and knowledge of FDA computer system validation requirements. Remember, the sponsor or software vendor can help, but they cannot completely address these obligations for you.
In this complimentary webinar, you will learn the key regulatory requirements a research site must be aware of before implementing eTools, including helpful tips on how to build a risk-based compliance plan. In addition, you will hear how a leading eCTMS software vendor, Bio-Optronics, is helping sites take advantage of eTools and remain compliant with FDA Part 11 requirements.
Who should watch
VPs and Executive Directors of Clinical Research Compliance or Operations at Research Sites, Hospitals, Health Systems, Academic Medical Centers or any other research organization looking to implement technology solutions in clinical research.
James Riddle, MCSE, CIP, CPIA, CRQM
James is VP of Client Services at Kinetiq. He previously worked as Assistant Director at the Fred Hutchinson Cancer Research Center and has over 15 years of experience leading private and academic human subject protection programs. He has been a site visitor for AAHRPP, is a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research. James served on the Board of the Northwest Association for Biomedical Research, and is a Certified IRB and IACUC Professional.
Kate Yawman is a Product Line Manager at Bio-Optronics. She partners with customers conducting clinical trials to deliver software that streamlines research management. Before taking on her current role, Kate had experience in both customer services and marketing, that she draws upon while planning the Clinical Conductor product roadmap to satisfy key market needs. Prior to joining Bio-Optronics Kate started her career in pre-clinical research at Johns Hopkins University and University at Buffalo.
Continuing Education Credits
This webinar is pre-approved for 1.0 contact hours of continuing education credit for the Certified IRB Professional (CIP) certification, and for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certifications. If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements. Information for CE credits for SOCRA can be found here. Visit our Webinars Help page for more information on certification credits.
Certificate of Attendance
You must watch this webinar in its entirety to receive a certificate of attendance. The certificate will include your full name and it will be emailed to you at the end of the webinar. Please note that if your organization has other staff members who wish to earn CE credits for this webinar, each person must register for and watch the webinar in its entirety in order to receive a certificate. Visit our Webinars Help page for more information on certificates of attendance.