Change Control for FDA Regulated Industries
Download or Read eBook Change Control for FDA Regulated Industries PDF written by David N. Muchemu and published by AuthorHouse. This book was released on 2007 with total page 150 pages. Available in PDF, EPUB and Kindle.
| Author | : David N. Muchemu |
| Publisher | : AuthorHouse |
| Total Pages | : 150 |
| Release | : 2007 |
| ISBN-10 | : 9781434314680 |
| ISBN-13 | : 1434314685 |
| Rating | : 4/5 (80 Downloads) |
Book Synopsis Change Control for FDA Regulated Industries by : David N. Muchemu
Book excerpt: 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 requirements
