Practical Approaches to Method Validation and Essential Instrument Qualification
Chan, Chung Chow
Sold by GoldBooks, Denver, CO, U.S.A.
AbeBooks Seller since 15 May 2019
New - Hardcover
Condition: New
Quantity: 1 available
Add to basketSold by GoldBooks, Denver, CO, U.S.A.
AbeBooks Seller since 15 May 2019
Condition: New
Quantity: 1 available
Add to basketPractical approaches to ensure that analytical methods and instruments meet GMP standards and requirements
Complementing 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 risk-based 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 systems
Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance―coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers―and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs
At 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.
CHUNG CHOW CHAN, PhD, is a Consultant for CCC Consulting, and the former president of the Calibration & Validation Group, a nonprofit organization dedicated to the art and science of instrument calibration and method validation.
HERMAN LAM, PhD, is the Principal of Wild Crane Horizon and President of the Calibration & Validation Group. Dr. Lam has developed and presented an instrument qualification and performance verification course for Agilent Technologies and other organizations in North America and Asia.
XUE MING ZHANG, PhD, is a Manager at Apotex, responsible for overseeing the development of stable liquid formulations. He also works on method development and validation for both instrument and chemical analysis.
"About this title" may belong to another edition of this title.
We ship from Colorado, U.S.A!
If you are a consumer you can cancel the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
INFORMATION REGARDING THE RIGHT OF CANCELLATION
Statutory Right to cancel
You have the right to cancel this contract within 14 days without giving any reason.
The cancellation period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the the last good or the last lot or piece.
To exercise the right to cancel, you must inform us, RushLtd, 6800 E 53rd Pl., 80022, Denver, Colorado, U.S.A., +1 (303)550-1251, of your decision to cancel this contract by a clear statement (e.g. a letter sent by post, fax or e-mail). You may use the attached model cancellation form, but it is not obligatory. You can also electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". If you use this option, we will communicate to you an acknowledgement of receipt of such a cancellation on a durable medium (e.g. by e-mail) without delay.
To meet the cancellation deadline, it is sufficient for you to send your communication concerning your exercise of the right to cancel before the cancellation period has expired.
Effects of cancellation
If you cancel this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to cancel with contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to us or RushLtd, 6800 E 53rd Pl., 80022, Denver, Colorado, U.S.A., +1 (303)550-1251, without undue delay and in any event not later than 14 days from the day on which you communicate your cancellation from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of cancellation
The right of cancellation does not apply to:
Model withdrawal form
(complete and return this form only if you wish to withdraw from the contract)
To: (RushLtd, 6800 E 53rd Pl., 80022, Denver, Colorado, U.S.A., +1 (303)550-1251)
I/We (*) hereby give notice that I/We (*) withdraw from my/our (*) contract of sale of the following goods (*)/for the provision of the following goods (*)/for the provision of the following service (*),
Ordered on (*)/received on (*)
Name of consumer(s)
Address of consumer(s)
Signature of consumer(s) (only if this form is notified on paper)
Date
* Delete as appropriate.
| Order quantity | 7 to 12 business days | 4 to 6 business days |
|---|---|---|
| First item | £ 3.23 | £ 11.41 |
Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.