2017 AM: K-2/3 - Anatomy and Autopsy of a Mock Inspection

2017 AM: K-2/3 - Anatomy and Autopsy of a Mock Inspection
K-2 & 3 – 53 minutes



The Anatomy of a Mock Inspection - Why We Do It and How



Dani Eaton, PRA International



There is no better way to prepare for a regulatory inspection than to practice with a “dress rehearsal”. Mock Inspections can benefit the team and the company by allowing the feel of the inspection process without as much pressure. During this presentation, we will examine how to conduct a mock inspection in a GxP environment with a focus on:

Review, preparation and organization of paper records

Interview preparation

Communication flows, both internal and with sponsors

Practicing data flows

Set up inspection and back rooms, including practicing the flow of information between the two

Highlight areas of concern

We will talk about tools and tricks for the successful conduct of a mock inspection in Phase 1 clinics, Phase 2-4 projects, and in Bioanalytical Labs. With the proper time and effort, the preparation for an eminent inspection can go from stressful and chaotic to cool-headed and organized.




Autopsy of a Mock Inspection - What We Did and Learned



Suzanne Olah, PRA Health Sciences



There is no better way to prepare for a regulatory inspection than to practice with a “dress rehearsal”. Mock Inspections can benefit the team and the company by allowing the feel of the inspection process without as much pressure. During this presentation, we will talk about the conduct of a mock inspection in a clinic and bioanalytical lab. Topics that will be covered include:

Conducting the Interview

Guidelines, tools, and reporting

Giving feedback

Benefit to the operations

Benefits to the QA teams

We will talk about the experiences – the good, the bad, and the ugly. We hope that you’ll leave wondering how your orginaization would fare during a mock drill.
Discounted member price: 20.00
30.00
You could save: 33%

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