Monthly Member Gift October 2013

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Welcome to Your Free Monthly Gift Package from ISPE

These gifts will be available to you through 30 November 2013.

Gift #1:

Pharmaceutical Engineering Preview: "Cloud Computing in a GxP Environment: The Promise, the Reality and the Path to Clarity"
by the GAMP Cloud Computing Special Interest Group (SIG)
Download the Article ( 863 KB)

The promises of cloud computing are certainly considerable: extremely fast and flexible solution delivery, on-demand scalability, high-demand business continuity services with easy solutions for backup and archiving.  All the things that are attractive as IT tries to support the challenges the life sciences industry faces while consequently being asked to deliver effective solutions at the same time as cutting costs without compromising quality, compliance, agility and flexibility.

This article explores the “promises” made for cloud computing versus the “reality” of its use in a regulated environment by examining delivery models available and the risks to which the industry may be exposed.  It proposes a way forward to be adopted by the GAMP COP Special Interest Group on Cloud Computing so as to assess the risks, identify gaps in “traditional control” and provide recommendations for the changing landscape of regulated IT controls. Enjoy this Members-only preview, from the January/February 2014 issue of Pharmaceutical Engineering!
 

Gift #2:

Process Validation Presentation: "Business Benefits of Using a Lifecycle Approach – ROI Model"
by Jenn Walsh, Associate Director Manufacturing Technology, Bristol Myers Squibb
Download Presentation Slides ( 570 KB)

Many conversations around Quality by Design and using a lifecycle approach to manufacturing focus on the benefits from a technical perspective. This presentation, from the recently concluded 2nd Annual Process Validation Conference, examines the business benefits of using a lifecycle approach. Topics discussed include the financial benefits of improved manufacturing and theoretical evaluations of ROI for a blockbuster product recall and a mature product sales loss.

For more on this topic, please join us for Ms. Walsh's presentation, "Practical Application of Lifecycle Approach to PV - ISPE PV Team Progress, Remaining Challenges and Recap of Issues and Solutions Discussed in the October PV Workshop," at the 2013 ISPE Annual Meeting.
 

Featured Member Benefit:

Relationships ISPE has with Regulatory Agencies around the World and Benefits to Members.

As an ISPE Member, you have the opportunity to interact with regulatory authorities in settings ranging from small workgroups to informal networking events, and to work hand-in-hand with regulators on key industry issues.

  • More than 500 professionals from more than 120 regulatory/public authorities in 42 countries are Members of ISPE.
  • More than 130 regulatory personnel have attended ISPE events, and have made more than 160 presentations.
  • Regulators have participated on ISPE event planning teams and in the development of ISPE publications.
  • ISPE Members have been invited to deliver presentations to regulators on drug shortages, dedicated facilities, and process validation and to provide training to regulators on Quality by Design and Risk Management.
  • ISPE Members are currently working with regulators on several key initiatives, such as defining quality metrics and modernizing blend uniformity/stratified sampling plans.

Explore ISPE's Regulatory Affairs Activities.

If you have feedback regarding your monthly gift from ISPE, including suggestions for future content, please contact Scott Ludlum at sludlum@ispe.org. 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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