February 2008, Volume XVIII, No. 1
 

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In This Issue

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Chapter President Rick Pierro shares his story about his mother's life threatening diagnoses with non-Hodgkin's lymphoma and her treatment with a drug manufactured by a local biotech.
Plan your attendance at the many exciting Chapter events - educational seminars, plant tours and more - that fill the next several months.
The November educational program explored different aspects of project management, including the creation, care and feeding of project teams and the development of a global project management standard for a multinational corporation.
Although rescheduled to January due to an ill-timed snowstorm, the annual holiday party still drew a crowd with its festive combination of food, drink and camaraderie.
In January, the Chapter devoted its educational program to the topic of regulatory documentation with an overview of the current worldwide standard for submission of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs).
Most projects involve the same questions and challenges regarding the integration of the Process Control System (PCS) with skid-based equipment. This case study contrasts two different approaches to PCS integration.
The author identifies the main Steam-In-Place (SIP) components, describes how component selection can shift costs between capital and operating budgets and explains the ROI calculation for an automated vs. manual steaming operation.
Industry News In Brief, a regular feature of the Boston Area Chapter Newsletter, presents news items concerning companies in the pharma, biotech, medical device and related fields, with an emphasis on companies with a local presence and topics of special interest to our readers.
Regulatory & Legislative Highlights, is a regular feature of the Boston Area Chapter Newsletter. It reviews recent actions by the FDA and other regulatory agencies and governmental bodies, both federal and regional, with the potential to impact the pharma, biotech and device industries, and related fields.
A list of new members to the Boston Area Chapter of ISPE.



 

Chapter Manager: Amy Poole, CAMI - Tel: 1.781.647.4773 and E-mail: ispe@camihq.com
 
   
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