21CFR Part 11 and Harmonization with 21 CFR Part 812 for Medical Device Trials
From Clinical Regulatory Compliance Training
Details
This session will review the dynamic changes in the conduct of clinical trials that extend beyond the GxP area with the use of lab information systems requiring computer validation and Software Development Life Cycle (SDLC) considerations. Participants will gain valuable insight into the regulatory requirements and how device trials have traditionally differed from pharmaceutical clinical trials.
Areas Covered
This webinar will provide a firm foundation into what type of Medical Device trials trail-blaze across the traditional clinical activities which require additional compliance for Electronic Records:
- Review 21 CFR Part 11 and the Predicate Rule;
- Review 21 CFR 832.40;
- Briefly overview actual case studies of what went wrong, how the risk of both financial and criminal liability could have been avoided through proper response to Warning Letters;
- Brief history on the Medical Device Safety Act, Social Media / Patient Reported Outcomes and pending legislation that will impact the medical device, generics as well as biosimilar trials.
Who Will Benefit:
Sponsors, Site Maintenance Organizations (SMOs), Clinical Research Organizations (CROs), 3rd party vendors as well as Financial Principals/Venture Capitalists wishing to engage in Pharma Partnerships will benefit. This webinar will provide valuable assistance to all regulated companies including:
- Project Managers, Directors and Leaders
- CRO Staff Members
- Site and Sponsor Staff Members
- Clinical Investigators and Study Coordinators
- Clinical Operations Directors and Senior CRAs
- Clinical Trial Managers, Monitors and Associates
- Medical Affairs and Clinical Operations Professionals
- Quality Assurance Personnel
- Regulatory Affairs Personnel
- Strategy Partnership Principals interested in Medical Device Trials
- Regulatory Managers
- IRB Members
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