Course Description |
This seminar is designed for medical device professionals including those in the In-Vitro Diagnostics Industry. It provides an overview of the device approval pathway for class 1, 2, 3 medical devices as well as IVD/LDT devices. It provides key clinical trial elements and an overview of monitoring including the FDA Guidance on a Risk-based monitoring approach to clinical research. This seminar also provides a solid review of monitoring activities using a focused quality approach and resolving GCP issues using CAPA plans. It consists of a comprehensive review of the GCP obligations of the sponsor and the investigator, the FDA Guidance: Investigator Supervisory Role, the regulations that protect the rights and safety of human subjects. This seminar reviews the key documents and elements of the clinical investigation at the site level, including the Investigator Study File and the Sponsor's Trial Master File, the report requirements and the reporting timeframes. Informed Consent, CAPA and AE Exercises are performed to enhance learning. |
Course Objectives |
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Daily Agenda / Course Topics |
Day 1 I. Overview of the Medical Device Approval Process
II. FDA GCP and ICH GCP
Day 2 III. Key Clinical Trial Elements
IV. Protection of Human Subjects
V. Monitor Role and Responsibilities
VI. Fraud and Misconduct
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Who Should Take This Course |
CRA's and other Device Industry professionals who want to gain knowledge about the device approval process, GCP governing IDE studies, and the monitoring role. |
Dates / Times / Accommodations |
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Contact Hours |
Florida State Provider #50-11408, Provider
approved by the California Board of Registered Nursing,
Provider #CEP 13617 for 11 contact hours. Credits can
be applied to ACRP and SoCRA certification. |
Cancellations and Substitutions |
Cancellations by registrants must be
provided in writing prior to the start date of the seminar,
such registrants shall receive a credit voucher toward
a future MRM seminar. Companies may substitute someone
registered with another participant at any time. MRM reserves
the right to cancel a seminar due to poor enrollment or
acts of nature and shall not be responsible for any airfare,
hotel, or other costs. MRM shall offer a credit voucher
to a future seminar or a complete refund for MRM Seminar
cancellations. Seminar topics and speakers may be subject
to change without any prior notice. |