These gifts will be available to you through 31 March 2013
Key Concepts related to the GAMP® Good Practice Guide on GxP Testing
Download Guide Chapter ( 760 KB)
Learn about the key concepts discussed in the recently-updated GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition), including product and process understanding, leveraging supplier involvement and more.
Quality by Design at Genentech and Roche in 2012
Dr. Lynne Krummen, VP, Global Head Technical Regulatory, Genentech Inc., USA
Download Presentation Slides ( 967 KB)
This presentation, from the 2012 ISPE Annual Meeting, focuses on lessons learned from Genentech and Roche's development and implementation of GNE/Ro large molecule QbD program and their participation in the US FDA's QbD Biotech Pilot Program.
The prevention of drug shortages is critically important to public health. As an ISPE Member or industry associate, you are uniquely qualified to help uncover the root causes of drug shortages. ISPE’s Drug Shortage Initiative, led by a task force of industry leaders, has been developing a survey designed to leverage your technical expertise and on-the-job experience to collect critical data on technical, scientific, manufacturing, quality and compliance issues that have resulted in drug shortages or have helped to avoid a drug shortage.
Your participation is vitally important to the success of this survey, and to ISPE’s efforts to support industry and global regulators in their efforts to prevent further drug shortages. Read our Drug Shortage Survey Details page for more information, and watch your inbox this week for your chance to participate!
Find the perfect job—or employee—through ISPE's Career Solutions.
Your ISPE Membership provides you with access to numerous complimentary resources—such as videos, webinars, articles and links to useful websites—to assist you in managing your career. You can also find, apply for, and be hired for the job of your dreams through ISPE’s Members-only Career Solutions.
If you're an employer, ISPE Career Solutions enables you to post jobs, gain access to well-qualified and highly trained candidates, and take advantage of valuable recruitment packages to help you find the perfect employee for the job.
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