Hosting a Compliance Inspection (single user digital version)
- Published
- Dec 2001
- ISBN
- 1930114397
- Pages
- 120
- PDA Item Number
- 17923
- Format
- PDF Single user
- Member Price
- $87.00
- Nonmember Price
- $108.00
- Government Price
- $48.00
Please sign in or become a member to purchase items from the PDA bookstore.
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.
Clearance Sale 40% Off!
Original Price US$145 PDA
Member, US$179 Nonmember, US$80 Government
Sale prices are already
displayed and will be reflected during checkout
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
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 Authors
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