Inspection Readiness – Plan (How to Handle Audit Questions)

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.  Note: This is the second e-Lesson in a series of 4.  Although this e-Lesson can be taken as a standalone, the trainee will get the maximum benefit if they have already taken the first e-Lesson in the series (CIR-800)

PART 2: PLAN

The second of the 4-part series, this e-Lesson walks you through the "Plan" phase of Project Management for the Clinical Trial Inspection Project, where you will focus on preparing the team members for their specific responsibilities, and use coaching and training to prepare for the Inspector's questions.  You will also plan out the basic logistics, including daily meetings leading up to the inspection, and discuss how to deal with issues and providing answers to the inspector.

Specific Responsibilities are described for:

- Regulatory Affairs Manager

- Clinical Quality Assurance Manager

- Phase III Study Director

- Phase III Study Manager

- Director of Clinical Operations

- Safety Physician

- Inspection Project Manager

Inspector question types described in this e-Lesson:

- Open-Ended questions

- Closed-Ended questions

- Leading questions

- Neutral questions

- Assumptive questions

- Repeat questions

SPECIAL RESOURCE: You can download a Sample Project Plan template with activities and tasks identified for the GCP Inspection Project Team.  

After completing this e-Lesson, you are ready to move on to part 3 of this series: CIR-802 "Inspection Readiness: Execute and Monitor"