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Hosting a Compliance Inspection (single user digital version)

By Janet Gough

PDF Single user
Gov. Price: $48.00Member Price: $87.00Nonmember Price: $108.00
  • Description
  • Table of Contents
  • Author's Bio

Here is the guidance you need to host a compliance inspection. This book provides a common-sense approach for assessing an incoming inspection and preparing for it, regardless of who is conducting the inspection.

Company and country cultures vary greatly, as do the regulations driving operations. For these and other reasons, no inspection ever duplicates another. The variables are many, but companies can keep themselves in a state of readiness for any inspection and here is how to do it.

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The book includes suggestions for ways to review your inspection procedures, assessing your inspection group, reviewing internal and supplier audits, inspection reports, and other records. It contains sample memos and letters, tips on training, tracking progress, feedback, and much more.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 17.2 MB)

Table of Contents:

Chapter 1 - The First Step

Being Proactive~Determining the Type of Inspection~Establishing a Preparation Team~Allowing Sufficient Preparation Time for an Inspection~Remaining Vigilant

Chapter 2 - The Homework
Reviewing the Company's Inspection Procedure~Assessing the Inspection Group~Trends, Rulings, and Guidance Documents~Service Providers~Professional Groups~Requesting a Plan~Providing Documents in Advance~Determining the Regulations that Will Drive the Inspection~Reviewing the Documents in Place~Reviewing Internal and Supplier Audits, Previous Inspection Reports, and Other Records~Assessing Actual Systems, Processes, and the Company Image~Confirming the Inspection and Calling for Action~Putting It in Writing

Chapter 3 - The Training
Assigning Inspection Roles~Other Participants~Preparing for a Mock Inspection~Anticipating Questions~The Mock Inspection~Reviewing the Mock Inspection~Confirming Readiness

Chapter 4 - The Inspection
Welcoming the Inspection Team~Initial Document Review~Interviewing Key Employees ~Reading the Inspector's Style~Employing Listening Skills~Walking the Walk~Tracking the Progress~Feedback During the Inspection~Corrective Action During the Inspection~The Close-Out Meeting~Exiting the Building

Chapter 5 - The Response
Understanding the Spirit of the Findings~Preparing the Response~Writing Guidelines~Disagreeing With an Observation~Preparing the Response~Receiving Further Regulatory Notification

Chapter 6 - The Next Step
Change Control~Effecting Improvement~Anticipating the Next Inspection~Retaining Records~Maintaining Readiness
References

About the Author

Janet Gough is the director of technical communications for Cerus Corporation, a biotech company. Her background includes consulting to the pharmaceutical industry and teaching technical writing and English as a Second Language (ESL) at the university level. She is the author of Write It Down: Guidance for Preparing Effective and Compliant Documentation, Second Edition. As well as the co-author of The External Quality Audit and The Internal Quality Audit

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