This book is written in a manner that can be read and understood by both, IT and non-IT professionals. It is divided into 10 independent chapters that describe a standard, auditable approach to validation packages and detail the roles and responsibilities for end
user management, user teams, IT infrastructure teams, software suppliers, quality assurance and quality control personnel, electronic archivists, and corporate governance.

There are 29 full-scale examples of validation document sets, policies and SOPs from real projects to illustrate the concepts discussed. An extensive glossary
of 80 validation-related terms provides the reader with quick access to definitions that are understandable by non-IT professionals.

To support focused anddistance learning, Dr. Stokes has made this book available in hard copy and also as electronic briefing units of specific chapters for download to PCs.

This book is available in both hardcover as well as in individual units that can be downloaded directly to your computer. Click button below for sample page and ordering details.
 

Clinical Research Guides

From GCP compliance and guarding against fraud to recruiting subjects and ensuring adequate
informed consent, the challenges posed by running clinical trials can be overwhelming.

These twenty guides, each written by a global subject matter expert,translate regulations
and best practice practices into real world guidance from drug discovery through post market
surveillance in the U.S., Europe and Asia.

Among many other subjects, you will gain a comprehensive understanding of:

- How to plan international development of new medicines
- Specific steps for registering products in the U.K. and Europe
- Regulatory requirements in major markets in the U.S. and Japan
- How to recruit investigators
- Tips on good clinical research practice
- Tips on writing reports
- Advice on budgeting of clinical research studies
 

A Free Example:

Learning, Training & Performance. You will receive this document free, submitted as e-mail attachement, just for creating a log-in account.