• Shopping basket
  • View

 
ISBN: 9780974367477 - Agent GXP FDA: Pt. 11
Bookmark and Share

Agent GXP FDA: Pt. 11

Free delivery on orders over £10 in the UK
Daniel Farb

ISBN: 9780974367477
Format: CD-ROM
Publisher: UniversityOfHealthCare


 Write a review

    Printable

Covers the FDA regulations on electronic signatures and records. This book deals with topics such as: history of Part 11; regulations of Part 11; and, implementation of Part 11. It is intended for both pharmaceutical/medical device manufacturing and clinical research personnel in FDA-regulated industries.

 

Synopsis

Details

Reviews

 
"Agent GXP FDA Part 11" teaches the FDA regulations on electronic signatures and records in the context of a spoof on a hostage rescue supervised by Pharm Mission Control. It is taught mostly through interactive questions and interviews with Agent GXP. The many difficult regulations of Part 11 are broken down into episodes that make the learning more memorable. This thorough course will teach you the: history of Part 11; regulations of Part 11; implementation of Part 11; applications of Part 11; and, ideas behind Part 11 in order to apply them to new situations and, how to prepare for enforcement of Part 11. This is particularly important for both pharmaceutical/medical device manufacturing and clinical research personnel in FDA-regulated industries, and provides an excellent glimpse of the issues that are likely to face HIPAA implementation of electronic records security measures. This course has been used by thousands of people in the pharmaceutical industry. When you successfully complete the exam, you will receive a certificate of completion that will demonstrate your mastery of this topic and provide documentation of GMP training. The estimated time for this program is 3-6 hours.
 
 

Buying Options

Other Versions

 
£153.96
Not available for sale

Sorry, this item is not available for sale at the moment.

Reserve in-store:
Not currently stocked in Blackwell shops.  Ask your local shop to obtain this title for you.