Monthly Member Gift September 2013

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Welcome to Your Free Monthly Gift Package from ISPE

We hope you enjoy your enhanced Member gifts, presented in honor of 
Member Appreciation Month.
These gifts will be available to you through 31 October 2013.

Gift #1:

Online Training Module: GMP Auditing for the Pharmaceutical Industry
Download the Module

Be among the first to view ISPE's new Expanded Online Training Courses with this free module from 7-module GMP Auditing for the Pharmaceutical Industry training course. This first module from the course includes a pre-assessment to use as a learning tool to test your knowledge, narrated slides and much more.

Gift #2:

Concept Paper: The Application of GAMP® 5 to GxP Compliant Clinical Systems
Download Concept Paper ( 2 MB)

As industry has transitioned from mainly paper-based processes to electronically supported processes, the need to validate and control computerized systems used to support clinical trials and the data they generate has increasingly become the focus of regulatory oversight. There is therefore a need for specific guidance for Good Clinical Practice (GCP) regulated systems, especially as such systems play a key role in the whole lifecycle of a medicinal product.

This Concept Paper, recently finalized by a team of clinical system experts from the GAMP® Community of Practice (COP) covers two main themes:

  • Identification of relevant similarities and differences between the use of computerized systems in GMP and GCP, and definition of some best practices and principles for applying GAMP® 5 to GCP systems
  • Demonstration of how these principles can be applied to the validation of a key system used in clinical trials—an Electronic Data Capture (EDC) system—and an exploration of particular aspects to be considered when implementing these systems

The 20-page document also contains a convenient table detailing the relationship between GAMP® 5 verification activities and EDC verification activities, as well as a list of common abbreviations and definitions.

Featured Member Benefit:

Target your Search with ISPE’s New and Improved Career Solutions.

Career Solutions has the tools and resources job seekers need to conduct a successful job search or manage your career effectively. Post a resume, search job postings, set a personal job alert, and build professional contacts through networking.

Employers find the right candidates by gaining access to some of the most qualified science and manufacturing professionals who are actively involved in enhancing our industry. ISPE Career Solutions saves employers time and money by enabling you to easily post jobs and find the best package to meet your recruitment needs.
Explore the new and improved Career Solutions.

If you have feedback regarding your monthly gift from ISPE, including suggestions for future content, please contact Scott Ludlum at Don't forget to review your Member Benefits on a regular basis to stay current and make the most of your membership!

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