by Emmet Tobin (Author)
At over 200 pages, this pocket book will bring you up to speed quickly on the requirements of process validation. It is divided into logical chapters that sets out the journey of validation in a clear fashion. Many components of Validation for medical devices are transferable. Understanding the fundamental principles of validation allows the reader to apply them to different products and different manufacturing processes. This book is ideal for professionals new to Process Validation. Although it has a practical approach, it is also suited to the academic.Chapter 1: Validation Planning, Chapter 2: Facilities And Utilities QualificationChapter 3: Equipment And Software ValidationChapter 4: Process ValidationChapter 5: Packaging ValidationChapter 6: Test Method ValidationChapter 7: MeasurementChapter 8: ISO 13485Chapter 9: Lean