21CFR Part 11 and Harmonization with 21 CFR Part 812 for Medical Device Trials


Conducting clinical trials in a rapidly evolving electronic environment presents a unique challenge to the medical device industry where not only quality (GLP/GMP) plays an essential role – but collecting accurate, maintaining viable data (GCP) as part of continuous process improvement (while mitigating risk) is an essential and critical component of the development paradigm. The complexity of medical device trials require adherence to 21 CFR Part 11 and Predicate Rules and must work in concert with 21 CFR 832.40. Additionally, many hybridized trials cross into the arena of Proof of Concept to allocate resources to devices and as well as biosimilars as part of the new of investigational products.

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.

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.

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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