Sandy, W: Good Laboratory Practice Regulations
Language: English
Published by CRC Press, 2007
Series: Book 20 of 80 - Drugs and the Pharmaceutical Sciences
- Hardcover
- New
Seller: moluna, Greven, Germanymoluna
AbeBooks seller since July 9, 2020
Condition: New
£ 177.58
Quantity: Over 20 available
Add to basketItem description from seller
Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Sandy WeinbergRecent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security o.
Seller Inventory # 595092869
- Title
- Sandy, W: Good Laboratory Practice Regulations
- Author
- Sandy, Weinberg
- Publisher
- CRC Press
- Publication year
- 2007
- Condition
- New
- Binding
- Gebunden
- Language
- English
- ISBN 10
- 0849375835
- ISBN 13
- 9780849375835
- Edition
- 4th Edition
- Series
- Book 20 of 80: Drugs and the Pharmaceutical Sciences
Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments.
Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated procedures…gives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documents…and details the FDA’s GLP inspection program.
"Synopsis" may belong to another edition of this title.
About the Author
"About the title" may belong to another edition of this title.
Shipping rates from Germany to U.S.A.
| Item | 16 to 45 business days | 16 to 45 business days |
|---|---|---|
| First item | £ 42.06 | £ 42.06 |
Payment methods
- Bank Wire Transfer
- Check
- Paypal
Store description
Online Handel nur mit Neubüchern
Seller's business information
Moluna GmbH
Engberdingdamm 27
Greven, Germany 48268
Terms of sale
About Us
Legal website operator identification:
Moluna GmbH
Represented by the general manager Helge Blischke
Engberdingdamm 27
48268 Greven
Germany
Telephone: 02571/5698933
Telefax: 02571/5698930
E-Mail: abe@moluna.de
VAT No.: DE296281834
listed in the commercial register of the local court Steinfurt
Commercial register number - Part B of the commercial register - 10553
We are a member of the initiative „FairCommerce“ since 24.07.2015.
For more information, see: www.haendlerbund.de/faircommerce.
Right of withdrawal
If you are a consumer you can withdraw from 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 withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal 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 last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from 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 withdraw from this 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 moluna, Greven, Germany, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal 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 withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.