GCP Inspection Readiness
Would you know how to prepare for a regulatory inspection if given two weeks notice? Do you know how to assign roles and responsibilities?
Do you know what the best practices are for inspection readiness and inspection management?
Would you be able to collaborate with a project team and identify risk areas that may be affected by an inspection?Preview Suite
Skillpad presents its brand new suite of GCP Inspection Readiness e-Lessons.CIR Inspection Readiness Suite
This complete suite of 4 e-Lessons is specifically designed to help you as a Sponsor prepare for, and successfully execute, a Good Clinical Practices (GCP) regulatory inspection. Using an engaging, scenario-driven approach, each lesson provides strategies as well as practical techniques you can implement right away as part of your GCP inspection preparations. Adopting a phased project management approach, each e-Lesson covers a different stage of the inspection readiness cycle to assist you in your overall preparation activities.
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CIR Inspection Readiness Suite
4-Lesson suite for in-depth knowledge, designed for:
- Inspection Readiness Project Managers
- Inspection Readiness Project Team Members
- Inspection Readiness Support Team Members
- Personnel in Clinical Quality Assurance, Regulatory Affairs, Study Management, Clinical Operations, Safety, Human Resources and Project Management and anyone who needs to play a part in Inspection Readiness activities.
Skillpad’s Inspection Readiness suite will provide you with the background and practical tools you’ll need to effectively implement an inspection readiness project.
You will be taken through the key phases of inspection readiness project management – Initiate, Plan, Execute & Monitor and Close.
The contents of each lesson are described in more detail in the individual lesson descriptions. It is recommended that the lessons be taken in sequence.
Duration: 80 minute suite (containing 4 lessons)
Assessment: 10 Multiple Choice Questions per lesson within the suite
Inspection Readiness – Initiate – (CIR-800)
The lesson describes the critical actions that must be taken in the period leading up to the inspection from receiving notice of an inspection to the project kick off meeting.
The tasks associated with the Initiate phase are identified and explained – confirmation of the inspection, identifying key personnel, defining roles, providing training and kicking off the project.
Inspection Readiness – Plan – (CIR-801)
The lesson identifies critical planning activities that must be undertaken before the inspector arrives on site. It also describes the design and implementation of the Inspection Readiness Project Plan, the responsibilities of personnel involved and how staff should be coached.
The “dos and don’ts” of interacting with an inspector are explained and the different types of questions (and suitable responses) that may arise during and inspection are explained and illustrated.
Inspection Readiness – Execute and Monitor – (CIR-802)
The Execute and Monitor phase of an inspection readiness project is the most varied and one of the most pressurized! This lesson focuses on how particular activities must be performed and by whom during the inspection proper.
The individual team member responsibilities are described with a focus on critical personnel. Furthermore, key tasks that are performed during this stage of the inspection are described, such as discussing known issues, preparing standard questions and answers and key documents, and monitoring completion of deliverables.
Prerequisites: CIR-800, CIR-801
Inspection Readiness – Close – (CIR-803)
The final lesson in the suite describes the procedures and tasks involved in closing out the inspection. Critical activities are preparing for and conducting the close out meeting with the inspector, responding to 483 observations and finalizing the internal report.
In addition, several scenarios are presented focusing on inspections going badly, going well and how to improve on borderline poor inspections.
Prerequisites: CIR-800, CIR 801, CIR-802