GAMP 5

iSpeak Blog
Background As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting...
Features
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...
Insights
Ten years after its publication, the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP∗ computerized system compliance and validation for companies and suppliers and is...
Training
GAMP 5 was published in 2008 to great acclaim around the world. Just having the guide published does not mean the benefits it offers will automatically be achieved. This seminar will look at some of the corporate and...
Training
Ever wonder whether your spreadsheet or other desktop application requires validation? This webinar helps you find out by providing deeper understanding for compliant end-user applications and the GAMP 5 Special Interest...
Online Learning Courses
The pharmaceutical industry is responding to the challenge of significantly improving the way drug development and manufacturing is managed. New concepts are being developed and applied, including science-based risk...
Training
How do you apply the new risk-based approach to IT infrastructure? Whether you are new to this or quite experienced you get useful and immediately applicable GAMP 5 guidance on: Understanding the scope of IT...
Training
This highly interactive classroom workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerized....
Training
This two or three-day fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry....