Lesson Code: CIR-800 (PREMIUM LESSON). Provides practical techniques and strategies for the "Initiate" phase of preparing for a Good Clinical Practice (GCP) Inspection using project management principles.
Skillpad's GCP Inspection Readiness suite is presented in a series of 4 e-Lessons built to help you prepare for a Clinical Trial Inspection at a Pharmaceutical or Biotech company. The e-Lessons are designed using an immersive real-world scenario, written by Skillpad's Compliance Subject Matter Experts, where you are the Project Manager in charge of the Clinical Trial Inspection Project.
Intended audience: Everyone participating in a Clinical Trial Regulatory Inspection. Emphasis on the Project Manager's coordination role, but extremely useful for all other members of the team.
Pre-requisites: Basic knowledge of GCP and regulatory inspections
PART 1: INITIATE
The first of the 4-part series, this e-Lesson walks you through the "Initiate" phase of Project Management for the Clinical Trial Inspection Project, from Inspection Notification to the Project Kickoff Meeting.
This e-Lesson explains:
- how and when the inspection notification is transmitted to the company
- how and why to confirm the inspection and validate the inspection notification
- how to identify the key players you will need on the Inspection Team, including the Core Team, Management Team, and Support Team
- how to define the roles of all the key players, and identify their training and coaching requirements
- how to plan and conduct the "Project Kickoff Meeting", and why it is such an important step
SPECIAL RESOURCE: In this e-Lesson, the trainee can download a PDF template of a typical GCP Inspection Readiness project timeline. Extremely useful for planning your next Inspection.
After completing this e-Lesson, you are ready to move on to the second part of the series: CIR-801 "Inspection Readiness: Plan"