We have now launched  On-line Knowledge Programs — the next generation of information delivery.

These programs are convenient and easily accessible and allow pharmaceutical manufacturing professionals to gain broad industry knowledge, career enhancement, and a competitive edge. Programs are 30, 45, or 60 minutes long; are pre-recorded lecture formats with activities, hot links, and printable presentations and supporting documents; and can be viewed for 14 days.  

The Programs include:

Product Development
Formulation, Clinical Phases, and Manufacture
Technology Transfer
Production Scale-up and Optimization 

Facilities and Equipment 
Design and Construction/Installation - Coming Soon!

Commissioning and Qualification as a Risk Management Strategy
Operation Maintenance 
Controls and Automation

Information Systems - Coming Soon!

Supply Chain Management
Materials Management
Operational Economics - Coming Soon!
Warehouse and Distribution Management 

Production Systems
Production Unit Operations - drug (small molecule) and biologics
Production Management
Production Control - Coming Soon!

Regulatory Compliance (Includes drugs, environmental, health, and safety)
Government Regulations - Coming Soon!
Standards, Practices, and Guides

Quality Systems
Risk Management and Quality Management Systems - Coming Soon!
Systems Validation - Coming Soon!

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ISPE will present the latest in technical education, case studies, and real world, industry-impacting information for the pharmaceutical manufacturing industry at its 2007 Annual Meeting at Caesars Palace in Las Vegas, Nevada, U.S., 4-7 November.
 

The 2007 ISPE Annual Meeting: “Delivering Today, Transforming Tomorrow” will focus on delivering what’s new, current, and relevant to the industry, focusing on fundamentals, best practices, transformation, and innovation.
More than 40 sessions – including regulatory workshops – will provide information and interaction on Product Quality Lifecycle Implementation (PQLI), personalized medicine, technology transfer, nanotechnology, real world project management, disposables, latest trends in laboratory design, and three newly-released ISPE technical documents. New to the 2007 ISPE Annual Meeting, sessions will be organized by seven tracks to help attendees choose the events that best meet their needs, or allow them to cross-train in areas of interest outside their fields. Tracks include:

• Regulatory/Compliance
• Facilities and Engineering
• Guides and Guidance Documents
• Manufacturing
• Innovation
• Investigational Products
• Project Management

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It’s time to get your submissions in for FOYA 2008. 

ISPE,  INTERPHEX and Pharmaceutical Processing magazine will sponsor the   2008 Facility of the Year Awards (FOYA) program and are officially calling for global pharmaceutical manufacturing organizations to submit details of newly constructed or renovated facilities.

FOYA, now in its fourth year, has quickly established pre-eminence as the program that recognises and disseminates best practices in the pharmaceutical manufacturing industry. It awards those companies that utilize new and innovative technologies to reduce the cost of production of high quality medicines and enhance capital project delivery.

This global program attracts submissions from more than 20 countries from around the world. Past winners have come from Belgium, Canada, China, Denmark, Germany, Ireland, Japan, the United Kingdom, and the United States.

“The addition of Category Winners to the 2007 Awards program has significantly improved the competition and has effectively enabled the judges to properly acknowledge those facilities that stood out and deserve special recognition,” stated Andy Skibo, 2007 Judging Panel Chair, and Vice President Corporate Engineering and Capital Projects for Amgen.

FOYA sponsors have streamlined the entry process for the 2008 awards program by developing a convenient online submission process. Submitting companies will now be able to download simplified forms for completion and then upload them to a secure site for review by the judges. The online submission form can be accessed at http://www.facilityoftheyear.org/PDFs/2008foyasubmissionform.doc.  

The judging panel will select the winner of the Facility of the Year Award, from amongst Category Winners that demonstrate excellence in:

• Process Innovation 
• Project Execution 
• Equipment Innovation 
• Facility Integration 
• Sustainability 
• Operational Excellence

Once the Category Winners are selected by the judges in early 2008, they will be recognized and introduced during Interphex2008 in Philadelphia, Pennsylvania, U.S. The announcement of the winner of the 2008 Facility of the Year Award will take place at ISPE’s Annual Meeting in October 2008 in Boca Raton, Florida, U.S. Pharmaceutical Engineering and Pharmaceutical Processing magazines will provide extensive coverage on the winners.

For complete information about the Awards program and submission procedures, as well as to download the on-line application forms, please visit www.facilityoftheyear.org. Specific questions can be addressed to Scott Ludlum, ISPE Director of Business Initiatives, by tel: +1-813-739-2284 or by e-mail: sludlum@ispe.org  

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ISPE will collaborate with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to co-host an interactive Workshop for the industry and its regulators — the first time that PIC/S has joined with another organization to co-host a workshop and the first time that PIC/S inspectors and regulators will collaborate with industry professionals.