ISPE has announced a major extension of its Product Quality Lifecycle Implementation® initiative (PQLI®) further into biotechnology. This significant development comes after the decision of the CMC-Biotech Working Group consortium to provide their A-Mab case study to ISPE. The public availability of the final version of this case study will be announced during the PQLI session at the ISPE 2009 Annual Meeting.   Read more…

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Now you can get event-related updates, post your thoughts, preview exciting gatherings, and experience everything that is the 2009 ISPE Annual Meeting. Stay connected during the before, during, and after the event by…

• Texting keyword ispe to 24463
• Regularly visiting the ISPE Blog at ISPE.org/blog
• Stopping into the ISPE Twitter page at twitter.com/ISPEorg
• Networking with colleagues at LinkedIn.com/companies/ispe
• Networking with colleagues at Facebook.com/ISPEorg

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“ISPE is sensitive to the fact that current economic conditions around the world make it difficult for pharmaceutical manufacturing professionals to obtain the knowledge and training they require,” said ISPE President and CEO Robert P. Best. Read more…

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“I’m very pleased with the diverse composition of our incoming Board of Directors,” said ISPE President and CEO Bob Best. “ISPE’s Members can only benefit from the myriad of backgrounds represented by our incoming Board in terms of geography, areas of interest, and areas of expertise.” Read more…

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GMP: USFDA GMP Inspection Approach for Quality Systems
This highly-interactive, pre-recorded online course reviews the quality system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. Quality system elements reviewed include: annual product reviews, compliant files, discrepancies and failure investigations, change control, reprocessing, returns/salvages, stability testing, quarantine systems, and validation/verification.

Click here for more information and to purchase the course from ISPE’s Online Store.

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