Inspection Readiness - Close


Lesson Code: CIR-803 (PREMIUM LESSON). Provides practical techniques and strategies for the Close phase of a Good Clinical Practice (GCP) Inspection using project management principles.


  • Category: GCP Inspection Readiness

Description

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 fourth 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 three e-Lessons in the series (CIR-800, CIR-801 and CIR-802)


PART 4: CLOSE

The fourth and final of the 4-part series on GCP Inspection Readiness, this e-Lesson takes you through the "Close" phase of Project Management for the Clinical Trial Inspection Project, where you will focus on these key tasks:

1. Preparation for the Closeout Meeting: you and the Core Team will get ready for the Closeout meeting with the Inspector by reviewing all the daily debriefing notes and preparing your verbal responses to the Inspector.  

2. Conducting the Closeout Meeting with the Inspector: you and your Team must be prepared to respond and interact correctly with the Inspector and let him/her know the written response is on the way. 

3. Respond to 483 Observations:  The inspection is over and the Inspector has left the facility.   Now it is time to produce the written responses to the Observations.  The key Team Members and Management must be fully engaged for a timely and accurate response.

4. Finalize the internal report:  as the Inspection Project comes to an end, a final report is required to address the actions taken and plan to capture the Lessons Learned.

5. Define the Lessons Learned:  you and the Project Team should take the opportunity to assemble all the Lessons Learned and ensure the Company benefits from this hard-earned knowledge in future inspections.

SPECIAL RESOURCES: This final e-Lesson in the series is 'resource rich' and includes downloadable PDFs that guide you through all the steps described above with sample questions and typical industry examples.  Behaviors and question/answer techniques are very important in this phase, and the Lesson offers highly descriptive guidance to help you and your team.