Quality Trends for Remote Audits in Clinical Trials
Date: September 15th
Time: 11 am PT / 2 pm ET
You're invited to an in depth discussion on quality trends for remote audits. Andrea Bradbury, Principal, Audens LLC and Rodd Schlerf, VP, SureClinical discuss major changes over the last 18 months and, more importantly, the continuing trends for remote audits.
We will take an in depth look at best practices for remote audits including security and technology, and explore if remote audits are here to stay, followed by a robust Q&A session.
Join us and learn more about what the pros are seeing.
Webinar highlights include:
- Streamlining remote audit processes
- Ensure remote audits are secure and compliant
- Discussing the future of remote audits in Life Sciences
Andrea Bradbury, Principal, Audens LLC
Andrea Bradbury is the MVP of quality assurance and compliance in the life-sciences industry. Andrea brings together the rare combination of business acumen, outstanding communication, and superlative technical expertise. She has headed successful quality and compliance departments at multiple clinical trial software companies, and developed QA departments from the ground up at startups Galt Associates, Clarix, ZenQMS, and Suvoda (which she also co-founded).
Andrea has extensive experience conducting CSV, GCP, GMP, GLP, and GCLP audits at companies throughout the United States, Europe, and Asia. She has worked with all of the world’s top pharmaceutical companies and most of the world’s top biotech companies.
A love of technology spurs Andrea to leverage new technology and principle-based compliance to enable innovation and streamline processes while maintaining regulatory compliance. This approach has produced a track record of success in start-up, turnaround, and growth environments.
Rodd Schlerf, VP, SureClinical
Rodd has delivered software technology solutions to the life sciences industry for over three decades, largely focused on eClinical cloud services.
For over 12 years, Rodd led the DocuSign life sciences market by embedding digital signature services into leading eTMF, CTMS, and QMS solutions.
Rodd has created value for hundreds of global life sciences and healthcare organizations by transforming manual, paper-based business processes to fully automated, digital operations. The delivered solutions have resulted in tangible ROI for clients in terms of cost reductions, increased productivity, quicker turn-around times, greater revenue, higher quality information and streamlined compliance.
This focus on solutions delivery has produced a track record of success in start-up, growth, and tenured environments.