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Courtroom Testimony

This course will introduce you to your role if you are called as an FDA witness. The course will help you distinguish among grand jury, deposition, declaration, and courtroom testimony. The course also discusses how to: prepare for testimony; identify the fundamental characteristics of appropriate courtroom conduct; and identify the components of effective testimony. The pre-requisites for this course include: Tour of FDA; Orientation to FDA/ORA Fieldwork; Expected Conduct of FDA Personnel; Food and Drug Law: FDA Jurisdictions; Food and Drug Law: Prohibited Actions; Food and Drug Law: Criminal Acts Violations; Food and Drug Law: Judicial Actions; Food and Drug Law: Imports and Exports; Evidence and Proof; FDA Establishment Inspections; FDA Establishment Inspection Reports; Sample Collection; and Preparation of Analytical Worksheets (ORA U).
$99.95

EU Medical Device Directive: Part I - Introduction (Chinese)

This training intends to provide basic information concerning the European Medical Device Directive and the CE marking of medical devices.
$99.95

ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials (Chinese)

ISO 14155 is intended to be applied worldwide to clinical investigations of medical devices in order to fulfill the various national, regional, and international regulatory requirements. In this course, the learner will be able to identify the specific requirements of ISO 14155. The learner will also be able to recognize the roles and responsibilities of sponsors and monitors in clinical investigations.
$99.95

ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials (Japanese)

ISO 14155 is intended to be applied worldwide to clinical investigations of medical devices in order to fulfill the various national, regional, and international regulatory requirements. In this course, the learner will be able to identify the specific requirements of ISO 14155. The learner will also be able to recognize the roles and responsibilities of sponsors a
$99.95

ISO 14155: Obligations of Sponsors and Monitors for Medical Device Trials (Korean)

ISO 14155 is intended to be applied worldwide to clinical investigations of medical devices in order to fulfill the various national, regional, and international regulatory requirements. In this course, the learner will be able to identify the specific requirements of ISO 14155. The learner will also be able to recognize the roles and responsibilities of sponsors and monitors in clinical investigations.
$99.95