Practical Guide to Quality Management in Clinical Trial Research
Regular price
€248.00
14 days return policy
Shipping & Delivery
A01=Graham Ogg
audit
Author_Graham Ogg
ber20
Business Excellence
capture
Car
Category=KJMQ
clinical data integrity
data
ECTD
EDC
EDC System
electronic
eq_bestseller
eq_business-finance-law
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
eq_non-fiction
file
GCLP
GCP Guideline
HPLC Machine
Hyper Text Markup Language
Ich
Ich GCP
implementing GXP quality frameworks
Individual's Training Record
laboratory accreditation
Lloyd's Register Quality Assurance
master
NATA
National Voluntary Laboratory Accreditation Program
personnel competency assessment
Ph Ar
pharmaceutical quality systems
Pharmacokinetic Blood Sampling
Pr Ep
QA Program
QA System
QA Unit
QC Sample
regulatory compliance strategies
Research Quality Assurance
septem
site
Site Master File
standard operating procedures
trail
Training Record
Product details
- ISBN 9780849397226
- Weight: 476g
- Dimensions: 156 x 234mm
- Publication Date: 01 Nov 2005
- Publisher: Taylor & Francis Inc
- Publication City/Country: US
- Product Form: Hardback
Secure
checkout
Fast Shipping
Easy returns
Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis.
The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.
