Title
Practical Approaches To Method Validation And Essential Instrument Qualification
Delivery time: 8-12 business days (International)
Practical Approaches To Ensure That Analytical Methods And Instruments Meet Gmp Standards And Requirementscomplementing The Authors' First Book, Analytical Method Validation And Instrument Performance Verification, This New Volume Provides Coverage Of More Advanced Topics, Focusing On Additional And Supplemental Methods, Instruments, And Electronic Systems That Are Used In Pharmaceutical, Biopharmaceutical, And Clinical Testing. Readers Will Gain New And Valuable Insights That Enable Them To Avoid Common Pitfalls In Order To Seamlessly Conduct Analytical Method Validation As Well As Instrument Operation Qualification And Performance Verification.Part 1, Method Validation, Begins With An Overview Of The Book'S Riskbased Approach To Phase Appropriate Validation And Instrument Qualification; It Then Focuses On The Strategies And Requirements For Early Phase Drug Development, Including Validation Of Specific Techniques And Functions Such As Process Analytical Technology, Cleaning Validation, And Validation Of Laboratory Information Management Systemspart 2, Instrument Performance Verification, Explores The Underlying Principles And Techniques For Verifying Instrument Performancecoverage Includes Analytical Instruments That Are Increasingly Important To The Pharmaceutical Industry, Such As Nir Spectrometers And Particle Size Analyzersand Offers Readers A Variety Of Alternative Approaches For The Successful Verification Of Instrument Performance Based On The Needs Of Their Labsat The End Of Each Chapter, The Authors Examine Important Practical Problems And Share Their Solutions. All The Methods Covered In This Book Follow Good Analytical Practices (Gap) To Ensure That Reliable Data Are Generated In Compliance With Current Good Manufacturing Practices (Cgmp).Analysts, Scientists, Engineers, Technologists, And Technical Managers Should Turn To This Book To Ensure That Analytical Methods And Instruments Are Accurate And Meet Gmp Standards And Requirements.
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We ship your order within 2–3 business days for USA deliveries and 5–8 business days for international shipments. Once your package has been dispatched from our warehouse, you'll receive an email confirmation with a tracking number, allowing you to track the status of your delivery.
Returns
To facilitate a smooth return process, a Return Authorization (RA) Number is required for all returns. Returns without a valid RA number will be declined and may incur additional fees. You can request an RA number within 15 days of the original delivery date. For more details, please refer to our Return & Refund Policy page.
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Warranty
We provide a 2-year limited warranty, from the date of purchase for all our products.
If you believe you have received a defective product, or are experiencing any problems with your product, please contact us.
This warranty strictly does not cover damages that arose from negligence, misuse, wear and tear, or not in accordance with product instructions (dropping the product, etc.).
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Frequently Asked Questions
- Q: What is the primary focus of the book 'Practical Approaches to Method Validation and Essential Instrument Qualification'? A: The book primarily focuses on ensuring that analytical methods and instruments meet Good Manufacturing Practices (GMP) standards and requirements, providing advanced topics on validation and qualification processes.
- Q: Who is the author of this book? A: The author of 'Practical Approaches to Method Validation and Essential Instrument Qualification' is Chung Chow Chan.
- Q: What topics are covered in Part 1 of the book? A: Part 1 covers Method Validation, including a risk-based approach to validation, strategies for early phase drug development, and specific techniques such as cleaning validation and validation of laboratory information management systems.
- Q: What can readers expect to learn about instrument performance in this book? A: Readers will learn about the principles and techniques for verifying instrument performance, including coverage of important analytical instruments like NIR spectrometers and particle size analyzers.
- Q: Is the book suitable for beginners in the field of analytical method validation? A: While the book provides valuable insights, it is more targeted towards analysts, scientists, engineers, and technical managers who already have some background in analytical methods and GMP compliance.
- Q: Does the book provide practical solutions to common problems in method validation? A: Yes, at the end of each chapter, the authors examine important practical problems and share their solutions, offering readers actionable insights.
- Q: How many pages does the book contain? A: The book contains a total of 416 pages.
- Q: What is the publication date of this book? A: The book was published on September 27, 2010.
- Q: What edition of the book is available? A: This book is available in its first edition.
- Q: In what format is the book available? A: The book is available in hardcover format.