An NSF International Company M16 - Combination Product Requirements - Combination Product Risk Management and Biological Evaluation – Key Issues
PrintPart of Medical Devices Module 16
£1470.00 exl VAT
About this course
A two day product safety course outlining the specific risks and expected controls for combination products. If you are involved in combination products, i.e. drug/device combinations, then you will be expected to demonstrate that you have taken into account the risks associated when the two entities combine. We explore typical aspects such as biocompatibility, drug efficacy, extractables and leachables as well as the subsequent expert opinion on expected controls. By the end of the course you should be able to prepare risk management documentation that is in line with regulatory agency expectations.
Who Should Attend
Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of combination products will benefit from this course.
