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

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Upcoming Events

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

Dates: 01 Jun 2015 - 03 Jun 2015

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02 Jun
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2015 FOYA Banquet
Washington, DC USA

Dates: 02 Jun 2015 - 02 Jun 2015

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14 Sep
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2015 Philadelphia Training
Philadelphia, PA USA

Dates: 14 Sep 2015 - 16 Sep 2015

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28 Sep
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2015 Barcelona Training
Barcelona, Spain

Dates: 28 Sep 2015 - 30 Sep 2015

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2015 Pharma EXPO
Las Vegas, NV USA

Dates: 28 Sep 2015 - 30 Sep 2015

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07 Oct
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2015 Process Validation Conference
Silver Spring, MD USA

Dates: 07 Oct 2015 - 08 Oct 2015

Mon
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

PTFE (Polytetrafluoroethylene) Teflon®
A fluoroplastic that is resistant to practically every known chemical or solvent in combination with ...

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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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

Compressed air particles according to ISO 8573-4:2001
Friday, 29 May 2015 10.05

risk review process
Saturday, 23 May 2015 00.05

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

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