Change Control for FDA Regulated Industries: A Risk Assesment Approach by Muchemu, David N.

Change Control for FDA Regulated Industries: A Risk Assesment Approach (Hardcover) (ISBN-13: 9781434314680)

Vendor: David N. Muchemu
Product type: Books
Format: Hardcover
$35.00
$35.00
$35.00
Subtotal: $35.00
Change Control for FDA Regulated Industries: A Risk Assesment Approach by Muchemu, David N.

Change Control for FDA Regulated Industries: A Risk Assesment Approach

$35.00
Change Control for FDA Regulated Industries: A Risk Assesment Approach by Muchemu, David N.

Change Control for FDA Regulated Industries: A Risk Assesment Approach

$35.00
Format: Hardcover
Description
Description
x
This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requir

Author: David N. Muchemu
ISBN-10: 1434314685
ISBN-13: 9781434314680
Publisher: Authorhouse
Language: English
Published: 10/13/2007
Pages: 148
Format: Hardcover
Weight: 0.83lbs
Size: 9.00h x 6.00w x 0.50d

Recently Viewed Products