Validating Medical Packaging

By: Ronald Pilchik

Write A Review

eText | 27 September 2002 | Edition Number 1

At a Glance

Format
ePUB

eText

$573.10

or 4 interest-free payments of $143.28 with

Instant online reading in your Booktopia eTextbook Library *

Why choose an eTextbook?

Instant Access *

Purchase and read your book immediately

Read Aloud

Listen and follow along as Bookshelf reads to you

Study Tools

Built-in study tools like highlights and more

* eTextbooks are not downloadable to your eReader or an app and can be accessed via web browsers only. You must be connected to the internet and have no technical issues with your device or browser that could prevent the eTextbook from operating.

The FDA establishes the manufacturer's responsibility for medical device packaging, but provides no direction on how to achieve compliance. Highlighting the recent development in industry regulations, this book demystifies the validation procedure. The author presents real-life examples and case studies, templates for creating and maintaining a validation file, and explains how the process and regulation works. He addresses the specific needs for validation of packaging for medical devices and covers laws, regulations, guidelines, and process capability studies. The book shows readers how to develop and implement a simple validation process for package design and processing.