21CFR Part 11 and Harmonization with 21 CFR Part 812 for Medical Device Trials (Clinical Compliance)
Venue: Online Event
|Event Date/Time: Aug 23, 2012||End Date/Time: Aug 23, 2012|
Why Should You Attend:
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 â€“ 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.