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Biotechnology Company Industrializing Training Courses In North America
4 training items found
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This Medical Device Software Development & Management package training will have 4 courses which covers FDA's Medical Device Software Regulation, Medical Device Software Verification and Validation, IQ / OQ / PQ Approach and IEC ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
The main purpose of stability program is to evaluate a shelf life for a product to enter a market and before that determine a safe stability profile during clinical trial. There are many guidance which showcase the best practices how to achieve a successful stability program and then specific guidelines are formulated for a particular product ex – ICH regulatory guidance, QBD, PQS, ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This medical device software development, verification and validation training package of four courses covers wellIEC 62304 requirements and explains risk based approach for validation using validation protocols and GAMP®. Medical device software can make or break a device. Badly developed, non-compliant software can compromise a device's safety and reliability. These four webinar recording ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
Medical devices cannot be shipped to Europe unless they are in full compliance with the European Medical Device Directive (MDD). The compliance requirements vary, depending on the classification of the device. It's not just the CE marking requirements that manufacturers and exporters have to worry about, but also the way the MDD is linked to the EU Clinical Trial Directive and ISO Certification ...