Program Description

Auditing Medical Device Clinical Investigations

Estimated Learning Duration of the Program:
Program Description:

Course Description
Bringing a medical device to the global market requires more and more clinical data that need to be generated in strict compliance with the applicable regulations. The industry must be prepared for answering critical questions from the regulators and medical community both prior to or after placing a device on the market.

Whether required by regulators or not, audits will allow the sponsor to gain additional confidence in the data that have been generated during clinical investigations and provide essential preparation of both the sponsor team and investigators prior to a regulatory inspection, which are bound to occur more and more. Auditing requires specific techniques and knowledge of the area that is subject to the audit.

The 3 course suite “Auditing Medical Device Clinical Investigations” provides a comprehensive overview that will prepare professionals to effectively conduct a clinical investigation audit which needs to not only reflect an accurate picture of the status of the clinical data, but also contribute significantly to improving the overall clinical investigation system both at the sponsor, CRO and investigation site.

“Auditing Medical Device Clinical Investigations” 3 course suite:
Course 1: Fundamentals of Auditing Medical Device Clinical Investigations
Course 2: Sponsor/Third Party Audits of Clinical Investigation Sites
Course 3: Auditing the Clinical Research Organization and the Sponsor

Learning Objectives:

Upon completion of this course, trainees will be able to correctly and successfully:

· Identify when a clinical investigation of a medical device should be audited

· Identify the areas/departments/teams/facilities that should be covered by the clinical audit program

· Comprehend the basic elements of an effective audit from planning to closure

· Recognize the applicable regulatory standards and decide which ones to apply for the audit plan

· Distinguish the reasons that require an Investigation Site and CRO audit

· Illustrate how to prepare for conducting an Investigation Site and CRO audit

· Characterize the relevant areas of the facility, staff, clinical investigation conduct and documentation that are to be included in the audit

· Write effective audit reports

· Identify corrective and preventive actions where needed

· Conduct closing activities, including a closing meeting

Program Pricing

Prices have not been set for this program.