1 training found
ComplianceOnline Training
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Clinical Regulatory Compliance Training
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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 ...