Monthly Member Gift August 2011

Make the Most of Your Membership!

Welcome to your free monthly gift from ISPE! Don't let a single ISPE Membership benefit go to waste - enjoy these FREE knowledge, community, and professional resources, available only to ISPE Members!

FREE Webinar for Members

In honor of our upcoming, first-ever all GAMP conference, Improve Productivity with Risk-Based Systems Validation, our FREE Members-only webinar this month is all about data integrity and validation, and is delivered by one of ISPE's premier GAMP Experts, Winnie Cappucci.

The continuous cycle of change to business processes, the need for business process consolidation, as well as business mergers and acquisitions are just some of the reasons why the migration and consolidation of data may be required. Data migration activities are often perceived as disruptive and a threat to data availability. Many data migration projects do not meet timelines and generate cost overruns. This 45-minute presentation provides guidance in hopes of providing good practices that properly define customer expectations, minimize risk and provide for appropriate planning and data integrity. It will identify and address some of the most common misconceptions, such as whether data can be fixed after it is migrated to the target system, or whether a data migration methodology is necessary. Watch the presentation now!

FREE Webinar: Data Migration and Data Integrity
Free to Members through 30 September, 2011

KNOWLEDGE

One of the chief benefits available to ISPE Members is the way the Society brings together industry personnel with regulators to foster understanding and work together on practical solutions to GMP challenges. This month's Knowledge resource is aimed squarely at helping you gain understanding of how the FDA's 2011 Final Guidance on Process Validation was shaped, straight from one of the regulators most intimately involved in the process.

Grace McNally, Senior Policy Advisor for the FDA CDER Office of Compliance in the Division of Manufacturing and Product Quality, is a member of several working groups dealing with process validation and is involved in developing training for the industry. Recently, she sat down with ISPE's Pharmaceutical Engineering magazine to share her experience on the effort it took to develop the 2011 Final Guidance on Process Validation, as well as her perspectives on the Guidance's key concepts. Read the article now ( 328 KB)!

As a reminder, Pharmaceutical Engineering magazine is available only to Members. You can browse back issues and search for specific articles by visiting the Pharmaceutical Engineering page on the ISPE website.

COMMUNITY

Do you follow ISPE on social media? ISPE maintains official Society pages on Facebook, Twitter, and LinkedIn. By connecting with ISPE on these sites, you have the opportunity to engage with ISPE Members and other pharmaceutical professionals at all levels of experience and from all over the globe in a fun, informal, virtual setting. Start conversations to problem-solve or network, keep current on ISPE news and events, or share photos, videos, or articles that you think your fellow industry-focused professionals will find interesting. Once you take the step to follow ISPE on the social media platform(s) of your choice, how much or how little you participate is up to you. Connect with us today!
 

PROFESSION

The deadline for the 2012 Facility of the Year Awards submissions is getting closer. As a reminder, Intent to Submit forms are due by 9 September, 2011, and final project submissions are due by 14 October, 2011.

Why submit a project for consideration for the Facility of the Year Awards? Well, for one, Category Winners of the Facility of the Year Awards are recognized as global leaders in pharmaceutical facility design innovation. Suppliers associated with winning projects are sought out as experts in their fields. Simply put, there is no other recognition program in the industry that has the same power to distinguish innovation and quality in the field of pharmaceutical manufacturing technology.

Get more information on eligibility and the submission process, or learn more about the Facility of the Year Awards program.

DID YOU KNOW?

Have you ever wondered exactly how new ISPE Guides get developed? Well, wonder no more! To ensure that our Guidance Documents live up to their reputation as solidly scientific, trustworthy expert solutions, each document goes through a thorough development process involving subject matter experts, staff, and regulatory authorities. Learn more about the Guidance Document development process ( 283 KB). To get involved with developing Guidance Documents or any of ISPE's many volunteer positions, visit the Volunteer Resource Center on ISPE's website.

TELL US WHAT YOU THINK

What did you think of this month's Gift offerings? Are there topics and resources you'd like to see covered in future gift emails? We want to know! Please send all feedback to rjones@ispe.org.