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A Message from ISPE President and CEO, John Bournas, 18 May 2015

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Upcoming Events

01 Jun
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2015 ISPE/FDA/PQRI Quality Manufacturing Conference
Washington, DC USA

Dates: 01 Jun 2015 - 03 Jun 2015

02 Jun
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2015 FOYA Banquet
Washington, DC USA

Dates: 02 Jun 2015 - 02 Jun 2015

14 Sep
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2015 Philadelphia Training
Philadelphia, PA USA

Dates: 14 Sep 2015 - 16 Sep 2015

28 Sep
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2015 Barcelona Training
Barcelona, Spain

Dates: 28 Sep 2015 - 30 Sep 2015

28 Sep
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2015 Pharma EXPO
Las Vegas, NV USA

Dates: 28 Sep 2015 - 30 Sep 2015

07 Oct
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2015 Process Validation Conference
Silver Spring, MD USA

Dates: 07 Oct 2015 - 08 Oct 2015

19 Oct
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2015 Raleigh Training
Raleigh, NC USA

Dates: 19 Oct 2015 - 20 Oct 2015

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Pharmaceutical Glossary

Sizing and Timing Analysis
(IEEE) A software V&V task to obtain program sizing and execution timing information to determine if ...

ISPE Initiatives

Quality Metrics
ISPE is leading the charge to bring industry and regulators together for open dialog and exchange.

Drug Shortages
ISPE’s Drug Shortage Initiative facilitates communication between the pharmaceutical industry and global health authorities to understand and address this complex problem.

Blend and Content Uniformity
An ISPE-sponsored group of regulators, industry, and academia are identifying alternative approaches to assess Blend and Content Uniformity.

Patient Initiative: Survey on Patient Experience with Clinical Trial Materials
A global survey on patient experiences with clinical trial materials, including the suitability of packaging, labels, technologies, transportation, and storage.

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Current Issue
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Online Exclusive Articles

Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework
by Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore, and Evdokia Korakianiti

Starting Materials Selection and Life Cycle Management
by Richard Andrews, Mike James, Luc Janssens, Paul Marshall, Frank Montgomery, and Ron Ogilvie

Establishing and Managing Processes Enabling Delivery and Returns of Investigational Medicinal Products (IMPs) to Patient’s Homes
by Massimo Eli, Catherine Hall, Marianne Oth, PhD, Adrian Peskett, and Esther Sadler-Williams

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Community Discussions

PP (polymer) piping for PW-loop
Thursday, 21 May 2015 12.05

Misconceptions and Misnomers 7
Tuesday, 19 May 2015 15.05

Operations Management CoP Steering Committee Seeks Volunteers
Thursday, 14 May 2015 14.05

OSD CoP Steering Committee Seeks Volunteers
Thursday, 14 May 2015 14.05

PQ of warehouse HVAC
Monday, 11 May 2015 00.05


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