What Will You Learn?
The book will teach you all you need to know about Good Documentation Practices.The use of GDP is required in both the U.S. and Europe by governing bodies, including FDAs CFR and EMEAs Eudralex. Any documentation that is used in support of manufacturing, laboratory, distribution, and clinical practices must adhere to GDP
Controlled documents are legal documents used in regulated environments that must be signed by the document's author(s) and approved by the appropriate governing body. Document dates must have an appropriate meaning and those signing the documents must be qualified for the content they are approving. The integrity of controlled documents should never be under question. Control must be shown at all times so that the content can withstand legal scrutiny.
Who Should Read This Book?
At around 65 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about Good Documentation Practices or want to brush up on your current knowledge this book is made for you!
We’ve broken down this book into five key sections:
- The Starting Line
- General Rules
- Corrections
- Logbooks
- General Test Results
Why buy from AskaboutValidation?
Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to GDP and you think it falls short of being everything you wanted, we’d like you to have your money back.
Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling.
What could be fairer than this?
About the Author
Don Hurd has over 30 years of experience in supporting development of real-time, embedded applications in regulated environments. He is an ASQ Certified Quality Auditor with diverse background providing a unique insight into achieving product quality and ensuring high productivity of development organizations. As VP Quality and Validation Services, he has ensured activities are always performed to meet product specifications and that all products and services delivered with the highest possible quality.
His pragmatic approach allows projects to adapt processes to best suit customer and project needs without sacrificing quality or compliance. Mr. Hurd holds a Bachelor of Science Degree in Computer Science from Texas A&M University, College Station, TX. He is an active member of the American Society for Quality (ASQ), holding leadership positions in both the Dallas/Fort Worth Biomedical Discussion Group and the Audit Special Interest Group (SIG).
Contact Us
If you would like to learn more about this book, before you purchase you can email us directly at books@askaboutvalidation.com or call us now on +353-1-443-4016
Looking forward to hearing from you!
